Inspections, Compliance, Enforcement, and Criminal Investigations

Miscellaneous Food Products - Vol. 2 (9/96)

GUIDE1TO INSPECTIONS OF MANUFACTURERS OF MISCELLANEOUS FOOD PRODUCTS - VOLUME II

1Note: This document is reference material for investigators and other FDA personnel. The document does not bind FDA, and does no confer any rights, privileges, benefits, or immunities for or on any person(s).

This guide is divided into multiple sections. Each section provides specific instructions and information applicable to the individual product or products covered. Prior to conducting any inspection involving any food product manufacturer, review the FD&C Act Chapter IV, Food, 21CFR 110, GMP's on Food, and the general inspectional instructions in IOM Chapter 5.

Caution: when sampling and preparing samples, do not use preservative agents in the process areas. These agents should be kept outside the plant entirely to avoid contamination of food products.

CONTENTS

Page 1: Section 1 - General

Page 3: Section 2 - Meat, Meat Products & Poultry - Edible Gelatin

Page 4: Section 3 - Soft Drinks and Water

Page 8: Section 4 - Baby Food Products

Page 12: Section 5 - Food Additives for Human Use - Dried Yeast

Page 16: Section 6 - Storage Facilities*

Page 24: Section 7 - Miscellaneous Food Related Items- Dinnerware

Page 26: Section 8- Mycotoxins in Foods * Includes sample collection instructions for filth and aflatoxins in corn.

Attachments

1. Dried Yeast Guidelines

2. Mycotoxin Sample Size

SECTION 1: GENERAL

The Inspectional Methods in this Section coupled with the broad general guidance provided in IOM Chapter 5 are designed to cover all aspects of an inspection including sanitation, manufacturing, microbiological problems, labeling, standards, GMP's, etc.

Often an in depth inspection is not necessary. In those instances you may be directed to cover items in a particular C.P., project, or assignment. In these instances, utilize only those applicable portions in IOM Chapter 5 and/or the assignment, program or current policy directives.

The Compliance Program Guidance Manual will provide specific instructions, the depth of coverage required, references, and aids in a specific compliance program area.

ESTABLISHMENT INSPECTION

The inspectional method provided below is a generalized inspection guideline and would be applicable to almost all inspections. This guidance should be used in conjunction with applicable CGMP's and the specific instructions furnished in other Inspectional Methods in this guide.

High humidity and the storage of certain products between 24o & 32oC (75o & 90oF) are the conditions which favor the growth of the organisms responsible for mycotoxins and aflatoxins. Therefore, coverage of a plant for possible contamination of this type requires a careful evaluation of plant operations from the microbiological standpoint as well as from the conventional filth, insect contamination and sanitation approach.

Raw Materials

Check premises for the presence of rodents, insects, birds, and other vermin which could be sources of contamination.

Evaluate plant storage facilities to determine if they are clean, dry, well ventilated and free from conditions conducive to mold, insect or bacterial growth.

Ascertain tests conducted on incoming raw materials, including results of these tests and acceptance criteria for filth, mold, chemical contaminants, pesticides, aflatoxin, bacterial load, deterioration, etc.

Determine disposition of rejected raw materials and the reason for rejection.

Examine food and color additives to determine if they are permitted and used at allowable levels.

Check usage of rodenticide and insecticides to ascertain whether they are permitted for use, used properly, and do not become contaminants.

Raw Agricultural Commodities:

Evaluate field management practices, including pesticide control, harvesting and transportation practices.

Evaluate the use of washing solutions, detergents, adequacy of rinsing and removal of soil borne bacteria.

Processing

Evaluate sorting and inspection effectiveness to eliminate wet, moldy, and decomposed raw materials from the plant processing equipment. Check for blending of sound stock with suspect material to dilute bacterial, mycotoxin, insect or chemical contamination (See Compliance Policy Guide 7120.14, Section 555.200 of current CPG Manual).

Observe product manufacturing operations in detail including mixing times and any times and temperatures in the process. Determine if appropriate procedures are followed by firm. Prepare a flow plan if this will assist in evaluating the firm.

Check equipment as to suitability for its intended use, type of contact surface, andpossible cleaning problems because of equipment construction, etc.

Determine if water used is from an approved source, or if from the firm's own well, how often it is tested to determine its quality.

Obtain and evaluate formulations including food and color additives.

Determine firm's equipment cleaning and sanitizing procedures and check effectiveness of these procedures.

If processing includes heating in the thermophilic bacterial growth range (112140oF/5060oC), determine if the heating/cooling steps go through that range as quickly as practical.

Evaluate product packaging operations, including any possible routes of contamination.

Determine and report the significance of and/or the key to the firms coding system.

Evaluate finished product storage and transportation vehicle conditions.

Sanitation

If the firm handles products that are susceptible to insect infestation, examine the processing system for insects.

Evaluate employee practices being alert to those which could contribute filth or bacteria to the finished product.

Verify adequacy of equipment and plant cleanup, storage of cleaned portable equipment and utensils, and sanitizing solutions used.

Determine adequacy of plumbing, i.e.; cross connections, waste disposal, etc.

Quality Control

Ascertain what finished product tests are performed for filth, bacteria, aflatoxin, standards, nutrients, etc. and evaluate the results of these tests.

If products are vitamin enriched, determine source of vitamins and audit controls utilized to ensure proper vitamin level. Review finished product testing for vitamin/mineral content.

Economics and Labeling

Audit firm's net weight and fill of container practices. See IOM 428 for guidance.

Review labeling for compliance with FPLA, NLEA and other applicable Acts. See 21CFR 101, 102, 104, 105, as well as the current Nutrition Labeling and Education Act (NLEA) and Domestic Food Labeling and Economics Compliance Programs for guidance. Also see DEIO 'Guide to Nutrition Labeling and Education Act (NLEA) Requirements'.

If the product is a standardized food, check for conformance with the applicable standard.

Review labeling of products promoted for special dietary use (i.e.; sodium, diabetes, caloric, infants, hypoallergenic). for compliance with 21 CFR 105.

Consumer Complaints

Review the firm's complaint file covering a reasonable period, i.e., past year, since last EI, etc. Tabulate the complaints versus the annual production of each product involved. Review may indicate a problem area which requires specific follow-up. See IOM 517 and 593.3, Item 14.

SAMPLE COLLECTION

See commodity specific inspectional methods contained in DEIO Inspection Guides, IOM 454.2 - Routing of Samples and the IOM Sample Schedules for guidance.

SECTION 2: MEAT, MEAT PRODUCTS & POULTRY -EDIBLE GELATIN

Gelatin is obtained by a partial hydrolysis of collagen derived from the skin, connective tissue, and bones of animals. The method of extracting the gelatin from the animal parts involves either acid (acid cure) or alkali treatments (lime cure). Concerns in this commodity have largely involved the use of unfit raw materials and insanitary manufacturing procedures.

ESTABLISHMENT INSPECTION

In addition to the instructions provided in IOM 530, direct attention to the followingareas when conducting inspections of gelatin producers.

Raw Materials

Review and evaluate testing of incoming raw materials, including testing for Anthrax.

Manufacturing Process

Evaluate the separation of processes involving raw materials, in-process and finished products to avoid cross contamination.

Determine in-plant tolerances for edible and technical grade products.

Detail any sales of "technical grade" gelatin to food channels or for use in foods not meeting quality standards for edible grade.

Be alert to the use of "technical grade chemicals" (if shipped to food channels) that are different from those used in edible gelatin. sulfur dioxide and/or hydrogen peroxide might be added for bleaching the gelatin and may also act as preservatives.

Observe the color, odor and clarity of finished gelatin. Edible gelatin is light in color in the dry state, exhibits little or no cloudiness in the fluid state, and little or no odor in warm water solution.

Compare "Pharmaceutical" grade specifications with USP requirements, drug labeling, etc.

Review finished product Q.C. records for bacterial levels including pathogens such as anthrax and salmonella.

Repackers and Users

Determine source of gelatin used. Any gelatin for food use obtained from technical manufacturers is suspect since they generally do not have facilities for the production of edible gelatin.

Document any food use of "technical grade" gelatin. Collect aseptic samples if the gelatin being used is not food grade.

SAMPLE COLLECTION

Bacteriological Analysis

Use aseptic technique. Collect a minimum of 10225gm (8oz) subs in duplicate per batch or lot. If analysis is for salmonella, follow instructions in IOM Sampling Schedule Chart 1.

Food Additives

Collect 10-225gm (8oz) subs in duplicate per batch or lot.

Organoleptic Examination and Filth

Collect 24225gm (8oz) subs in duplicate per batch or lot.

SECTION 3: SOFT DRINKS AND BOTTLED WATER

ESTABLISHMENT INSPECTION-SOFT DRINKS

For safety reasons, do not examine the bottle filler or crowner while either is in operation. If you are near this equipment while it is in operation, wear adequate protective clothing and safety glasses. Filler valve levers on reservoirs of pressurized fillers have been known to break and fly from the machine causing considerable damage to the object or person they strike. Bottles are also subject to breakage and result in flying glass. Safety glasses and protective clothing should also be worn around bottle washers to avoid caustic soak splash.

Be aware of other hazards, such as the use of ultraviolet lights as mold and bacterial inhibitors in the liquid sugar systems. Even though these systems are generally sealed, the surge tanks have service ports from which UV light can leak and lead to retinal damage if protective UV goggles are not worn. See IOM 141 and other portions of IOM Subchapter 140 et al for additional safety precautions.

In addition to instructions and information provided in IOM Subchapter 530 and 21 CFR 129, direct attention to the following areas when inspecting soft drink bottlers.

Processing

Determine in-plant storage time for returned bottles. Dirty returnable bottles should be washed as soon as possible after return.

Determine what tests are conducted on incoming cans with pull tops to ascertain if solvent was completely removed from the vinyl epoxy coating of the can's interior.

Give special emphasis to bottle washing including mechanical brushing, water pressures and temperatures, soak time, cleaning solution concentrations, rinses employed, etc.

  1. Check washer closely while operating.
  2. Examine area under bottles at the intake end. The amount of trash will give an indication of the degree of attention given this equipment. Examination of empty unwashed returnable bottles has shown that only 12% contain cigarette butts and other trash. If you find numerous cigarette butts in this area, it may indicate irregular cleaning. The operation of the washer may be impaired, and other necessary cleaning and maintenance may have been ignored.
  3. Determine the strength and temperature of the caustic soak solution (3% and 54.4o C (130o F) are minimal guideline figures). If paper labels are removed in the washer, use a test kit to check the caustic strength frequently because the label glue tends to neutralize the caustic. Determine how often bottle washing solutions are changed and what steps are taken to assure adequate wash solution concentration.
  4. Determine the speed at which the bottle washer is operated for the various size bottles. Excess speed may prevent draining and thus prevent subsequent sprays from entering the bottles. The bottles which spend the least time in the washer may not be adequately washed, and have the greatest chance of containing mold or foreign material when candled. Some firms perform caustic carryover tests which shows the efficiency of the rinse.
  5. Determine the number of wash and rinse sprays that are plugged, and if there is sufficient water pressure. This can be done by opening an access panel to a set of sprays. If you cannot see individual sprays except for those on the end, and a considerable amount of water splashes from the opening, this indicates that most sprays are open and there is sufficient water pressure. However, a cracked or broken water pipe at the access panel can cause a flood of water, indicating proper operation, when in fact no water isreaching the nozzles. Do not open panels in caustic rinse area.
  6. Check the alignment of the wash and rinse sprays with the bottle carriage. Unaligned sprays are not effective, even if all sprays are open.

If the bottle washer is not functioning properly, check for mold using methylene blue in bottles at the discharge of the bottle washer. Use the following procedures:

Note: Obtain permission from firm to utilize this procedure, prior to using. Use caution to avoid spilling the dye and plan for proper disposal.

  1. Place a funnel in the bottle to be examined.
  2. Pour methylene blue solution into the bottle to about 1/4 to 1/3 of the bottle capacity.
  3. Remove the funnel and place it into the next bottle to be tested.
  4. Rotate the bottle so that the stain is spread over the inside surface of the glass.
  5. Pour off excess methylene blue into the next bottle and rinse the bottle with water.
  6. Examine bottle, mold will retain the blue color after rinsing.
  7. Repeat procedure in subsequent bottles.
  8. Collect bottles retaining the blue color as part of your filth exhibit.

Check use of any mechanical candling or examination devices and determine if they are operating properly.

Observe unwashed returned bottles as they are placed into the bottle washer. Determine whether filthy bottles or those containing foreign objects are being introduced into the system. Examine approximately one-thousand unwashed bottles and report the percentage containing foreign objects and describe the objects.

Examine a number of washed bottles manually rejected because of filth or foreign objects, not glass breakage. Estimate the percent rejects per one-thousand washed bottles. Also describe foreign objects in filled bottles rejected either manually or mechanically.

Examine washed bottles passed for filling. Describe any bottles observed to be in an objectionable condition.

Sanitation

If possible, open filters and examine residues. Take down demountable sanitary pipe at one or more points in the syrup line. Check inner surfaces of pipes, pumps, valves, and filters for slime, mold, and other filth and determine condition of pipe sections by swabbing with a sterile cloth fastened over a clean pipe brush.

To adequately examine the bottle filler, it must not be operating. If management will not stop production for your examination, it can be examined during lunch breaks, stops between products, or after production has been completed. Particular attention should be given to filling valves, especially the sealing gasket which covers the mouth of the bottle. These gaskets tend to be cut and scored by glass from broken bottles and fragments from bottle explosions. The rough surfaces and cuts are difficult to clean and provide excellent sites for mold growth. You may notice a screen in the filler valves (when viewed from the bottom) which causes a uniform fill rate. It is not intended to remove any foreign material from the product.

Management may decline to open some equipment, especially if they do not have spare gaskets to replace those which may be torn during disassembly. Examination of one product pathway is possible without equipment disassembly. Insert clean cotton swabs (such as those on 6 in. wooden sticks) into the filler valve from the bottom, and swab around the nozzle. Remove and examine the swab for dark residues or particles. If any are found, collect them (and the end of the swab) as part of your filth exhibit. It is advisable to collect these swabs even though no residue or particles are visible.

Investigate and describe the cause of any excessive breakage of bottles on the production line and the occurrence of "exploding bottles".

Observe filling operation for a period of time and estimate how often bottles explode if the potential for glass contamination is high.

Determine how bottle handling lines and filling machines are shielded to protect bottles from glass from exploding bottles.

Ascertain glass control following bottle explosions, i.e., line shutdown, glass cleanup, bottles examined for glass, etc.

If insanitary conditions or deficient control practices are observed, candle a minimum of twenty cases of warehouse stocks. If mold is suspected, give preference to older stocks. If plant operations appear satisfactory, candle at least five cases of finished product.

Generally, avoid candling products with a citrus or other natural fruit juice base. The pulp present in those products is very difficult to differentiate from contaminants.

Finished product should be examined in several ways.

  1. Do not shake the bottle or invert it, as this causes carbonation bubbles, which may disperse small particles, and make their positive identification difficult. Shining a light at an acute angle to the top surface of the product in the bottle will reveal any visible particles on the surface. In some cases, discs of mold may be found covering the entire surface. This may be the result of a bent cap or an improper seal, allowing air to enter the bottle. Close examination of the surface will usually reveal small particles. This may be "crown dust". "Crown dust" is the small pieces of paint chipped off the crowns as they tumble in the crown hopper. This material can be found in and on the cappers and crowners. The paint used on the crowns is reported to be approved for use on food contact surfaces. The status of "crown dust" as a contaminant has not been defined at this time, but have resulted in recalls.
  2. Examine the contents of the bottle, disturbing the contents as little as possible. Shine a light through the contents at the bottom and twirl the bottle. This will cause any sediment or particles on the bottom to rise one or two inches into the product. These can be any of several items; mold, yeast, "crown dust", fibrous material (from plant material, water treating systems, etc.), or other contaminants. Generally "crown dust" and fibrous material will appear as very small, up to 1/16" diameter light colored particles. Yeast may appear as light colored particles. Mold generallyappears as dark colored irregularly shaped particles, 1/16" diameter or larger, whose outside edges are often filamentous. Small dark particles may be pieces of carbon from the water treating system.
  3. The construction of some bottles may require inverting for candling. This procedure makes identification of small particles difficult, as they can be confused with carbonation bubbles. They can be differentiated as carbonation bubbles will rise, while contaminants will fall. Also examine the bottom of the bottle for sediment.

Syrup swirls can be confused with contaminants. They are caused by incomplete mixing, or product separation with age. The syrup and water are not uniformly mixed, and when the bottle is twirled the syrup appears, as a wisp. However, the syrup swirl will not have a definite shape and will disappear with agitation.

Oil separation in cola products can be confused with contaminants. The oil collects on the glass at and just below the product level in the neck of the bottle. It appears as a cream colored film, which disappears upon agitation. This is most noticeable in quart or larger sizes.

Evaluate can and non-returnable bottle cleaning procedures. Determine if they complete a wash cycle, are rinsed or are air blown and vacuumed.

SAMPLE COLLECTION

Investigational Samples

Where inadequate bottle cleaning and inspection procedures or other insanitary practices are encountered, collect factory samples and exhibits of:

  1. Filled bottles that have passed inspection and contain foreign material.
  2. Filter residue and swabs.
  3. Bottles with visible filth found while candling warehouse stock.
  4. Other exhibits necessary to develop the evidence of insanitary practices.

Suspected filth collected from ceilings, walls, and equipment, for mold examinationmust be collected, handled and submitted in a manner which prevents drying. Follow procedures outlined in IOM 427.6.

Official Samples

Filth and Sanitation:

  1. Visible filth - Candle a minimum of five-hundred bottles, or the entire lot if less than five-hundred bottles. Collect as official samples, those bottles which contain visible filth up to forty-eight bottles.
  2. Microscopic filth - Collect a representative sample from the lot to total forty-eight units.

Food and Color Additives:

  1. Collect a sub-sample of the color or food additive in question and sub-samples of the product in which it is being used. Make every attempt to arrange for collection of an interstate shipment of the adulterated product before attempting a 301(k) case.
  2. Collect a representative sample from interstate shipment to total six units.

Labeling:

Check product labeling to determine if it complies with NLEA requirements. Reference 21CFR 100, 101, 104 and 105 and DEIO 'Guide to Nutrition Labeling and Education Act Requirements'.

ESTABLISHMENT INSPECTION-BOTTLED WATER

Bottled water regulations are found in 21CFR Parts 129 (GMPs) and 165.110 (identity and quality standards). A final rule was published on November 13, 1995 (effective May 13, 1996) that: (1) recodified the quality standard in 165.110 (b) (c) and (d) that was previously found in 103.35; (2) revised the definition for bottled water to include mineral water (with certain exceptions) and ingredient uses of bottled water; and (3) defined artesian, ground, mineral, purified, sparkling bottled, spring, sterile, and well water. The quality standard was also amendedMarch 26, 1996 (effective September 23, 1996) to establish or revise allowable levels for 13 chemicals.

Processing

Verify that the plant's product water and operational water supply is obtained from an "approved source". See 21CFR 129.3 for guidance. Check and report the firm's sampling and analysis schedule for source water. Review Quality Standards below for determining compliance for sampling and analysis frequency.

If the labeling of the bottled water makes a claim concerning the source of the water (e.g., spring water) verify the source complies with the definitions in 21CFR 165.110(a).

Inspect the washing and sanitizing procedures for containers used for bottled drinking water according to instructions provided in the processing section under Soft Drink Establishment Inspections.

Inspect to determine if the process or the equipment for the treatment of product water is effective in preventing adulteration of the product. This applies to processes such as distillation, ion-exchange, filtration, ultraviolet treatment, reverse osmosis, carbonation, mineral addition, or any other process.

Determine that the bottling operations are conducted in a separate room from all other plant operations to protect against contamination, as required by 21CFR 129.20(a).

Verify that each unit package is identified with a production code identifying a particular batch or segment of a continuous production run and the day produced. Establish whether the plant keeps and maintains records. Review the records for the types and volume of product produced, production dates, lot number(s), and the distribution of the finished products.

Sanitation

Determine that the plant is operating in a clean and sanitary manner (see 21CFR 129.37). Evaluate and determine that sanitizing operations for product water contact surfaces and other critical areas effectadequate sanitization. Sanitization treatments must meet the following minimum times, temperatures and/or concentrations (see 21CFR 129.80(d)):

  1. Steam or hot water in an enclosed system - 170°F for 15 minutes OR, 200°F for 5 minutes.
  2. Chemical sanitizer having an equivalent bactericidal action to 50 ppm available chlorine for 2 minutes at 57°F when used as an immersion or circulating solution.
  3. Chemical sanitizer having an equivalent bactericidal action to 100 ppm available chlorine at 57°F when applied as a spray or fog.
  4. Ozone water solutions must be 0.1 ppm ozone for 5 minutes in an enclosed system.

Inspect filling, capping and sealing operation according to instructions in Processing for Soft Drink Establishments above. Determine if a procedure is in place to reprocess or reject unsatisfactory containers found during bottling. Containers which are not satisfactory shall be reprocessed or rejected. At least once every 3 months, the firm shall sample and examine at least four containers and closures before filling and sealing for microbiological contamination (see 21CFR 129.80(f) for compliance standards).

Quality Standards

Bottled water, including mineral water (with certain exceptions), shall conform to the quality standards set forth in 21CFR 165.110(b), or labeled in accordance with 165.110(c). Evaluate the firm's compliance to standards by determining whether the firm analyzes each type of product it produces. Minimum requirements are: (a) One test annually for chemical contaminants; and (b) Weekly test for microbiological contamination (see 21CFR 129.80(g) for compliance procedures). Also evaluate whether the firm analyzes the source water. Minimum requirements are: (a) One test annually for chemical contaminants; (b) One test every four years for radiological contamination, and (c) Weekly test for microbiological contamination in source water obtained from other than apublic water supply (see 21CFR 129.35(a)(3) for compliance procedure).

Sample Collection

Follow guidelines for soft drink establishments on when to collect investigational or official samples. Sample size is 10 subs, 1 collected from each of 10 shipping cartons, chosen randomly. For 702(b) portion collect in duplicate.

SECTION 4: BABY (INFANT & JUNIOR) FOOD PRODUCTS

Infant Formulas

Establishment Inspection

The Infant Formula Act of 1980 and the 1986 amendments to that Act added a number of new Sections to the FD&C Act. Section 704(a)(3) gives investigators the right to examine and copy all records "bearing on whether the infant formula manufactured or held ... meets the requirements of Section 412." Section 412 in part deems any infant formula that does not contain the required nutrients at the level specified to be adulterated. It further requires FDA to promulgate regulations concerning quality control requirements, good manufacturing practices, and record-keeping. FDA has stated that batch records, test data, and similar records have a "bearing" on whether an infant formula has the proper nutrient composition. Based on this section of the FD&C Act a firm must make available to an investigator for examination and copying, batch records, quality control records, records containing nutrient test data, test methodology, and similar documents.

Section 201(aa) of the Act defines infant formula and Section 301(s) identifies the acts that are prohibited. Under section 412(g) of the Act, an infant formula manufacturer is required to make and maintain records showing thedistribution of their product in order to effectively monitor recalls of their product(s) if necessary.

In addition to the information and instructions in the current compliance program 7321.006-Infant Formula Program-Import and Domestic and IOM 530, direct attention to the following areas when inspecting infant formula producers:

Before conducting inspections of infant formula manufacturers become familiar with 21CFR 106-Infant Formula Quality Control Procedures regulations (requirements of which are very specific) and 21CFR 107 -regulations covering infant formula labeling and recall procedures. If the infant food is a LACF product, also inspect in accordance with the Low Acid Canned Foods Regulations (21CFR 108.35 & 113) and DEIO inspection guide: 'Guide to Inspections of LACF Manufacturers' (which will issue in the near future. If the firm pasteurizes or condenses, and/or dries infant formula ingredients, such as nonfat dried milk or dried whey, also cover these operations in accordance with instructions in DEIO inspection guide: 'Guide to Inspections of Dairy Product Manufacturers'.

Raw Materials

Determine compliance with 21CFR Section 106.20- Ingredient Control.

Determine firm's criteria for accepting or rejecting incoming raw materials and obtain copies of raw material specifications. Determine what types of tests are done on incoming lots.

Obtain copies of suppliers certificates or guarantees for premixes. Determine when each nutrient in the premix is analyzed for by the infant formula manufacturer to confirm guarantees and certifications.

Report changes in ingredients. List source and form of Vitamin K, iron, and other vitamins and minerals used in manufacture of product.

Determine disposition of rejected material and reason for rejection.

Determine how firm identifies and rotates incoming raw materials.

Determine how often old lots of raw materials are retested, and the extent oftesting on raw materials with elapsed guarantees, particularly premixes.

Ascertain how raw materials are transferred from the storage area to the manufacturing area and what records or controls are maintained for this transfer procedure

Review records pertaining to food packaging materials to verify compliance with indirect food additive regulations.

Manufacturing

Obtain copies of formulation for each batch reviewed. Include:

Complete list of ingredients, highlighting any changes in ingredients from those reported previously.

Accurate listing of weight or measure for each ingredient.

Any calculated excess or deficiency of critical ingredients (i.e., vitamins, minerals, etc.)

Complete manufacturing directions concerning premixes, slurries, suspensions, etc.

Describe in detail the manufacturing procedure for each product covered. Include:

A block flow diagram showing each item of processing equipment, labeling each, and indicating the process flow through the entire process. Indicate all ingredient additions (including entry points of each nutrient required by Section 412(i) of the FD&C Act) and any pre-processing performed on the ingredients before addition. Determine any critical parameters, i.e., inlet and outlet temperature, pressure, time intervals, etc., and list on the diagram. As previously noted, if applicable, cover firms operations as a LACF or dairy product manufacturer under applicable regulations and Inspection Guides.

In addition direct coverage to the following areas:

Verify how raw materials are measured, weighed, and any calibration of weighing or measuring equipment.

Determine if manufacturing instructions are followed, e.g.: components added when required and premixes, etc. mixed and heated for required times and/or temperatures.

Carefully inspect each critical temperature measuring point in the process. Determine thetype of thermometer, scale division, condition, location, date last calibrated, and method of mounting. Describe time/temperature relationships.

Inspect each mixing operation in the process stream and any premixing operation of an ingredient. Determine whether mixing of liquids is done in a closed system where all parts of the liquid are treated equally, i.e.; by an agitator or recirculation by means of a pump. Determine whether dry ingredients are blended in a closed system, i.e.; a vee-blender or a closed ribbon blender, to assure uniform dispersion, or by adding to a continuously discharging conveyor or feeder.

Inspect all homogenizing or colloid milling operations to determine whether the output of the homogenizer is discharged into a separate tank (to assure that all parts of the process stream receive the same treatment) or is it recirculated back into the feed tank. If possible, it is important to measure the temperature rise in the fluid as a result of the homogenizing operation, since this may constitute an unplanned heat treatment to the fluid which may affect the stability and nutritional quality.

What controls does the firm have over the manufacturing procedure. Determine how firm assures adequacy of mixing, homogenicity of suspensions, etc?

How often and how are control samples collected?

Does the firm have criteria for changing formulation or manufacturing procedures following analysis of in-process control samples.

Inspect finished product packaging operation.

Quality Control

Has a master manufacturing order been prepared and approved for each formulation?

Is the firm following SOP's which assure and verify the addition of each ingredient specified in the manufacturing order?

Are firm's master manufacturing order and SOP's in conformance with the requirements of 21 CFR 106?

Prepare chart indicating the composition of premixes, if any, and at what stage of processing nutrient levels are verified.

Is each batch analyzed for every required nutrient by the manufacturer either at the raw material, in-process, or final product stage? Summarize this information on Attachment B of the Infant Formula CP.

For in-process batches analyzed for nutrients as specified in 21 CFR 106.25(b), review assay records for the past three months.

Determine if firm has tested for vitamins A, E, B1, and C at the "final product stage". Final product stage means the point in manufacturing at which the infant formula is homogeneous and not subject to further degradation due to processing (i.e., in can). Determine other finished product specifications and analyses performed including protein, fat, moisture, vitamins, minerals, bacterial load, etc.

Review selected assay results for past three months, for batches of finished product analyzed as specified in 21 CFR 106.30(b)(1) and 21 CFR 106.30(b)(2).

Review and copy representative records of microbiological testing including testing for Salmonella, Listeria monocytogenes, Staphylococcus aureus, Escherichia coli, Coliform, Fecal Coliform, Bacillus cereus, and Aerobic Plate Count, and any testing conducted by contractors or another government agency.

Have stability tests been conducted to ascertain products shelf life? For finished product batches which are analyzed as specified in 21 CFR 106.30(b)(3), verify SOP's are being followed for testing and sampling. Review test results.

Report all new or reformulated products manufactured since the last inspection. Report all testing (chemical, biological, and clinical) done on new or reformulated product.

When analytical records are incomplete or not available at the plant being inspected, but are located at another plant, requests for such information should be made to the appropriate district office.

Exempt Infant Formulas

Determine if the manufacturer is following the same QC program for exempt and non-exempt infant formulas. If a different program is used for exempt infant formula, document each step in the program and explain why the manufacturer is using a different QC program.

Audits

Review record of manufacturer's audits to determine that there is a record of audit completion and the procedures used. Determine if the audit includes review of GMP and QC requirements of 21 CFR 106, 107, 110, and 113, if applicable. If the firm is not following their own auditing procedures document deviations.

Record Retention

Determine that manufacturers retain records of:

  1. Food packaging materials subject to 21CFR 174.5;
  2. Nutrient premix testing;
  3. Guarantees given by premix suppliers;
  4. Nutrient testing for quality control, and confirmation that final products contain nutrient levels required by Section 412(i)of the Act (also covered in 21CFR 107.100);
  5. Nutrient testing conducted at final product stage for vitamins A, B1 (thiamine), C, & E;
  6. Distribution of infant formula necessary to effect and monitor recalls in accordance with 21CFR 107 Subpart E;
  7. Microbiological testing including finished product testing for Salmonella, Listeria monocytogenes, Staphylococcus aureus, Escherichia coli, Coliform, Fecal coliform, Bacillus cereus, and Aerobic Plate Count;
  8. Audits; and
  9. Consumer complaints

Refer to 21CFR 106.100 for specific requirements regarding record retention.

Complaints

Review firm's complaint files for the past year concerning potential health issues and follow-up as necessary. Determine compliance with 21CFR 106.100(k).

Tabulate the types of complaints and compare with the annual production. Only summary comments on the nature of complaints and numbers of complaints, categorized as to types, should be included in the report. Complaints found, which in your view represent serious public health matters, shall be specifically reported and made as confidential attachments to the report. No attempt should be made to assess the relative significance of a specific complaint to public health in the EIR.

Distribution/Recalls

Does the firm have an existing record file showing the distributions of product , and could they perform an effective recall in compliance with 21CFR 107.200 based on their records? Describe in detail what type of record system is currently being used. If the firm does not have an existing record file determine what the firm would do in order to meet the requirements of the regulations.

Refusals

Document all refusals, particularly those concerning records of nutrient test results, microbiological test results, consumer complaints and product distribution. Consult with your supervisor. Your district should consult with CFSAN Office of Special Nutritionals (202) 205-5372 before undertaking any action based on refusal to provide access or copying of any record.

Code Dating Information

Evaluate compliance with the requirements of 21 CFR 106.90.

Ascertain if coding information is used by the firm to control the finished product in the market place, and how the firm has outdated product removed from the marketing channels, (manufacturing representative visit, retail store management, etc.). Determine disposition of outdated product and amount disposed of in the last year.

Interpret the coding system to aid in counterfeit investigations.

Labeling

Review labels for compliance with regulations. Infant formula labeling has to comply with 21CFR 105.65 and 107 subpart B. All other baby food products have to comply with 21CFR 101-Food Labeling [see 'Guide to Nutrition Labeling and Education Act (NLEA) Requirements', Exemption and Special Labeling Provisions section, provision # 17].

Sample Collection

The infant formula compliance program-7321.006 contains explicit instructions for sample collection, and required analysis, at firms assigned for coverage under this program. Reference the compliance program for sample collection instructions for nutrient and microbiological analysis. Instructions provided below are for analysis more general in nature.

Investigational Samples

Collect factory food and in-line samples to document violations uncovered.

Official Samples

  1. Filth
    1. Powder: Twelve retail units in duplicate of the same code.
    2. Liquid: 248 oz. units or 484 oz. units of the same code.
  2. Microbiological: See compliance program
  3. Canned Food: See IOM Sample Schedule Chart 2.
  4. Labeling: Three retail units.

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