Sirob Imports, Inc. 4/26/13
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
158-15 Liberty Avenue
Jamaica, NY 11433
April 26, 2013
WARNING LETTER NYK-2013-13
VIA UNITED PARCEL SERVICE
Nicholas Boboris, President
Sirob Imports, Inc.
515 Broadhollow Road
Melville, New York 11747
Dear Mr. Boboris:
Between October 10 and 23, 2012, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 7 and 21 Gear Avenue, Lindenhurst, New York, where you manufacture acidified foods and juice products. The inspection revealed serious violations of the regulations for acidified foods (Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control (21 CFR Part 108) and Part 114, Acidified Foods (21 CFR Part 114)). Furthermore, our inspection documented serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations (CFR), Part 110 (21 CFR 110). Accordingly, we have determined that your food and acidified food products are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (“the Act”) [21 U.S.C. § 342(a)(4)], in that have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. In addition, we found that you have serious deviations from the FDA's juice processing regulation (21 CFR Part 120). These deviations cause your lemon and lime juices to be in violation of 21 CFR Part 120, promulgated under the authority of Section 361 of the Public Health Service Act (PHS Act).You can find the Act, the Acidified Food regulations, PHS Act and the juice HACCP through links in FDA's home page at http://www.fda.gov
As an acidified food processor, you are required to comply with the Act and the federal regulations relating to the processing of acidified foods and current good manufacturing practices. These regulations are described in 21 CFR Part 108, Emergency Permit Control, and in 21 CFR Part 114, Acidified Foods. The Emergency Permit Control regulation was issued, in part, pursuant to Section 404 of the Act (21 U.S.C. § 344). A temporary emergency permit may be required for acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR Part 108, Subpart B, including registration and filing of process information, and the mandatory requirements of 21 CFR 114.
We have received a letter dated November 13, 2012 from Peter Boboris in response to the FDA 483 Inspectional Observations issued to your firm on October 23, 2012. The November 13, 2012 response is inadequate because it lacks supporting documentation to show any of the promised corrective actions have been implemented. Furthermore, the November 13, 2012 response lacks merit because, as noted below many of the deviations are repeat observations from previous FDA inspections, to which you promised similar corrective actions in writing. These corrective actions were either not taken as promised, or not sustained to prevent reoccurrence of the deviations.
During our inspection, we observed the following significant violations:
1) As a commercial processor engaged in the thermal processing of acidified foods you must, not later than 60 days after registration and prior to the packing of a new product, provide the Food and Drug Administration information as to the scheduled processes including conditions for heat processing and control of pH, salt, sugar, and preservative level, and source and date of the establishment of the process, for each acidified food in each container size, as required by 21 CFR 108.25(c)(2).
Specifically, your firm has failed to file a scheduled process for acidified foods that your firm manufacturers, including but not limited to garlic in water in 7.5 oz., 8 oz., 12 oz., 32 oz. glass jars, and 32 oz. and 1 gallon plastic containers. This is a repeat observation from the June 2006 and June 2010 inspections.
Your response indicates you require assistance from your consultant who is in Europe until December 6, 2012. However, as of the date of this letter, we have not received your scheduled processes.
2) Your firm failed to thermally process the garlic in water (acidified food product) to destroy vegetative cells of microorganisms of public health significance as required by 21 CFR 114.80(a)(1).
3) Your firm must ensure that each container is marked with an identifying code specifying the establishment where the product was packed, the product contained therein, and the year, date, and period during which it was packed, as required by 21 CFR 114.80(b).
This is a repeat observation from the June 2010 inspection. You failed to provide any evidence that you have implemented your promised corrective action of coding acidified food container in a manner that compiles with this regulation.
4) You must ensure that your processing and packaging systems are under the supervision of a person who has attended and satisfactorily completed a school approved by the Commissioner as required by 21 CFR 114.10.
You are the only person at the firm that has appropriate training and do not regularly supervise the processing and packing of acidified foods manufactured by your firm. You were also cited for this observation during the February/ March 2006 inspection.
5) You must maintain records of examination of raw materials, packaging materials, finished products, and supplier’s guarantees or certificates to verify compliance with FDA regulations and guidelines or action levels as required by 21 CFR 114.100(a). Our investigator noted you do not maintain any of the aforementioned records.
This is a repeat observation from the June 2010 inspection. The November 13, 2012 response fails to provide evidence that you are now maintaining appropriate records.
6) You must develop, or have developed for you, a written hazard analysis to determine whether there are food hazards that are reasonably likely to occur for each type of juice that you process, and you must have and implement a written HACCP plan whenever that hazard analysis reveals one or more food safety hazards that are reasonably likely to occur, to comply with 21 CFR Parts 120.7(a) and 120.8(a). However, your firm does not have written hazard analyses or written HACCP plans for your shelf-stable 100% lemon juice and lime juice, which you manufacture, to control the hazards of pathogens, chemicals, heavy metals, pesticides, and/or metal.
Furthermore, you must include in your hazard analysis and HACCP plan control measures that will consistently produce, at a minimum, a 5 log reduction of the pertinent microorganism for at least as long as the shelf life of the product when stored under normal and moderate abuse conditions, to comply with 21 CFR Part 120.24(a). The "pertinent microorganism" is defined as "the most resistant microorganism of public health significance that is likely to occur in the juice," 21 CFR 120.24(a).
Your November 13, 2012 response failed to include any hazard analysis or HACCP plan.
7) You must have and implement written procedures that describe the product specifications and affirmative steps for any juice you import into the United States to ensure that the juice has been processed in accordance with 21 CFR part 120 to comply with 21 CFR 120.14. However, you did not have such written procedures, nor did you have product specifications or affirmative steps for the lemon juice concentrate from (b)(4) and lime juice concentrate from (b)(4) you import into the United States.
Furthermore, the documentation provided in your November 13, 2012 response did not include such written procedures, nor did it include product specifications or affirmative steps sufficient to show conformance of the juices to 21 CFR Part 120.
8) You must monitor conditions and practices during processing with sufficient frequency to ensure conformance with current good manufacturing practice regulations, to comply with 21 CFR 120.6(b). However, your firm did not monitor safety of the water, prevention of cross contamination from insanitary objects, maintenance of hand-washing and toilet facilities, and exclusion of pests with sufficient frequency. Specifically:
a) On October 12, 2012, at your 7 Gear Avenue, Lindenhurst, New York facility, an employee was observed filling brine barrels with a garden hose (not food grade) connected directly to the potable water supply with no backflow protection device or air gap installed.
This is a repeat observation from the June 2010 inspection. Your November 13, 2012 response indicates new food grade hoses were purchased and being used. This will be confirmed on our next inspection. However, your response does not address the use of any backflow prevention or any air gap devices;
b) Throughout the inspection, food handlers were observed to enter your firm’s processing rooms and put on disposable gloves without first washing their hands. Employees wearing disposable gloves were observed doing multiple tasks such as breaking down boxes, handling garbage, picking up barrels of product from the floor and then returning to ready-to-eat food handling operations without changing or sanitizing their gloves.
This is a repeat observation from the June 2010 inspection. Your firm’s November 13, 2012 response indicates you have hired a firm to train your employees in proper food handling procedures. This response is inadequate because you did not provide any evidence to show how you are going to train your employees, when the training will occur, and what measures were taken to protect food against contamination prior to the training;
c) Three employees throughout the inspection were observed wearing unsecured earrings while working in various areas of the facility.
Your November 13, 2012 response stated simply that the observation was addressed and resolved. This is inadequate because it does not provide evidence that employees have been provided training to prevent this issue from occurring in the future, and/or an SSOP that is being used to monitor this deviation;
d) Your firm lacks hand sanitizing preparations and a sanitary towel service or suitable hand drying device at sink and toilet facilities throughout the facility.
Your July 12, 2010 response stated you had purchased and installed hand sanitizer in each department. Your November 13, 2012 response also indicates hand sanitizers have been purchased for each department. This response is inadequate because you did not provide any evidence that hand sanitizers were purchased and installed; and
e) On October 12, 2012 approximately twenty fresh rodent pellets were observed in your packaging area. In addition, approximately fifteen fresh rodent pellets were observed on cardboard boxes in the loft storage area above the walk-in freezer. The loading door located adjacent to your firm’s packaging area was left open throughout the inspection. There are no effective measures being taken to control rodent activity at the facility.
This is a repeat observation from the June 2010 inspection. Your firm’s November 13, 2012 response indicates you have hired (b)(4). This response is inadequate because you have not provided any information to show the nature of the services (b)(4) will provide. Furthermore, the response does not address doors to your facility being left open for extended periods of time. We note that your July 12, 2010 response to a similar deviation also indicated that you had hired (b)(4).
In addition to the juice HACCP SSOP violations noted above, we also observed the following serious deviations from the requirements of the Current Good Manufacturing Practice Regulations outlined in 21 CFR Part 110:
9) Based on the violations that follow, your firm failed to provide appropriate training to food production employees in proper food handling techniques and food-protection principles to ensure a level of competency necessary for production of clean and safe food as required by 21 CFR 110.10(c).
This is a repeat observation from the November 2005 and June 2010 inspections. Your July 12, 2010 response to this deviation indicated that you were in the process of developing training. Your firm’s November 13, 2012 response also indicates training is in development. This response is inadequate because to-date you have not submitted evidence that appropriate training has been provided to any of your employees.
10) You must ensure that all persons working in direct contact with food conform to hygienic practices to the extent necessary to protect against contamination of food, including wearing suitable outer garments, to comply with 21 CFR 110.10(b)(1). However, our investigator observed your employees were repacking ready-to-eat products including olives, capers, and pepperoncini without wearing sleeved garments and their bare arms were in direct contact with the ready-to-eat foods. Furthermore, our investigator observed your employees repacking ready-to-eat food products while wearing soiled personal clothes.
This is a repeat observation from the June 2010 inspection. Your July 12, 2010 response to the deviation indicated that uniforms were rented on a daily basis and being worn by your employees. Your firm’s November 13, 2012 response also indicates you have ordered uniforms for all of your employees. This response is inadequate because you did not provide any information about what corrections will be taken in the time period before the uniforms will be made available to your employees,any evidence to show that you ordered uniforms, or when your employees will be wearing the uniforms, and whether the employees will be trained to properly use the garments to protect against contaminating ready-to-eat food products.
11) You must maintain buildings, fixtures, and other physical facilities of the plant in a sanitary condition and keep them in repair sufficient to prevent food from becoming adulterated within the meaning of the Act, and to comply with 21 CFR 110.35(a). Specifically:
a) The tile floor in your firm's ready-to-eat cheese and olive repacking room was cracked and missing several tiles and grout. An accumulation of stagnant, pooling liquid was noted on the floor throughout the inspection while various products were being repacked;
b) Concrete floors throughout your firm’s brining/processing room were pitted, uneven and cracked. Cracks and pits in this floor were filled with deep, stagnant liquid. Employees throughout the inspection were observed walking through the pooled liquid while rolling hand trucks and manual forklifts through the water, and continuing into other food storage and processing areas; and
c) Ceiling panels in brining/processing room located directly over exposed ready-to-eat products were open throughout the inspection. In the cheese packing room, hanging electrical wires and metal support beams were exposed over products.
This is a repeat observation from the June 2010 inspection. Your July 12, 2010 response to the deviation indicates actions have been taken to address these issues. Your firm’s November 13, 2012 response also indicates these issues have been addressed. This response is inadequate because you did not provide any evidence to show that these observations have been corrected.
12) Your firm failed to inspect and handle raw materials as necessary to ascertain that they are clean and suitable for processing into food and stored under conditions that will protect against contamination as required by 21 CFR 110.80(a)(1). Specifically:
a) Two bags of citric acid were observed being stored directly on the wet floor in the processing room;
b) In the loft area above the freezer, spillage of open bags of chili powder and oregano was observed; and
c) Outside of your detached warehouse (7 Gear Ave.) barrels that contained brining products and ingredients were observed uncovered and exposed to the environment.
This is a repeat observation from the June 2010 inspection. Your July 12, 2010 response to the deviation indicated your uncovered drums stored outdoors were being covered. Your firm’s November 13, 2012 response indicated the issues have been addressed and new procedures have been implemented. This response is inadequate because you did not provide any evidence to show you have corrected the issues, you did not provide the new procedure for our review, and you did not provide any evidence that your employees have been trained on the new procedure.
13) Your firm failed to provide sufficient space for storage of materials as necessary for the maintenance of sanitary operations and the production of safe food, as required by 21 CFR 110.20(b)(1). Specifically, in the walk-in freezer, walk-in cooler and the loft above the walk-in freezer, our investigator observed numerous pallets of assorted foods, raw materials, and packaging materials being stored directly against walls, preventing inspection of the walls along the interior perimeter of your facility and the floor-wall junctions.
This is a repeat observation from the November 2005, the February/March 2006, and the June 2010 inspections. Your March 15, 2005 response indicates the lack of storage space was from one large shipment and that raw materials are not exposed in the warehouse at any time. Your July 12, 2010 response indicates the process of providing sufficient space for storage has started and is ongoing. Your firm’s November 13, 2012 response indicates you are in the process of moving products around to address this concern, your lack of sufficient space is from a 2010 building fire, and that another building is being built to address the lack of space. This response is inadequate because it fails to provide evidence that you have sufficient storage space, or any timeline for when you will have sufficient storage space, and/or any interim measures put in place to provide sanitary operations and the production of safe food.
14) You failed to provide adequate lighting in areas where food is examined, stored, or processed as required by 21 CFR 110.20(b)(5). Specifically, inadequate lighting was observed in your walk-in cooler where various ready-to-eat products and raw materials were stored. In addition, inadequate lighting was observed in the storage loft located above your walk-in freezer.
This is a repeat observation from the November 2005 and June 2010 inspections. Your July 12, 2010 response indicates the observation is fully complied with. The November 13, 2012 response indicates new lighting will be installed throughout the warehouse wherever it is needed. This response is inadequate because it does not provide any evidence that new lighting was purchased and/or installed, nor does the response indicate when new lighting will be purchased and/or installed.
15) You failed to have smoothly bonded or well maintained seams on food contact surfaces to minimize accumulation of food particles, dirt, organic matter and the growth of microorganisms as required by 21 CFR 110.40(b). Specifically, the weld on your olive processing table in the brining room, which is used for rinsing and re-brining various acidified ready-to-eat products, does not have a smooth bond on the food contact surface.
The November 13, 2012 response indicates the observation has been addressed and resolved. This response is inadequate because you did not provide evidence showing or indicating how the observation has been resolved.
16) You failed to have an accurate indicating thermometer, temperature measuring device, or temperature recording device in each freezer and cold storage compartment used to store food capable of supporting the growth of microorganisms as required by 21 CFR 110.40(e). Specifically, your firm does not have a temperature indicating device to monitor the temperature of your walk-in cooler where items such as ready-to-eat cheese and vacuum packaged sun-dried tomatoes were stored. In addition, your firm does not have a temperature-indicating device to monitor the temperature of your walk-in freezer where a variety of food items are stored.
This is a repeat observation from the June 2010 inspection. Your July 12, 2010 response indicates a thermometer was purchased and installed. The November 13, 2012 response also indicates your firm purchased and installed thermometers. This response is inadequate because your firm did not provide any evidence that thermometers were actually purchased, and installed, and whether any temperature monitoring procedure was implemented.
17) Your firm failed to adequately maintain an instrument used for measuring conditions that control or prevent the growth of undesirable microorganisms as required by 21 CFR 110.40(f). Specifically, on October 12, 2012 an employee was observed conducting pH meter readings of your garlic in water without rinsing the pH probe with distilled water after calibrating, and prior to taking the reading of this ready-to-eat food.
This is a repeat observation from the June 2010 inspection. Your July 12, 2010 response indicates that you trained your employees to use the pH meter. Your November 13, 2012 response indicates you have purchased distilled water. Your response is inadequate because your firm did not provide any evidence that employees were trained to properly calibrate and use the pH meter.
18) Employees were observed to be drinking beverages in areas where food was exposed [21 CFR 110.10(b)(8)]. Specifically, on October 12, 2012, an employee was observed drinking a beverage while packing olives in the cheese/ olive packing room.
This is a repeat observation from the November 2005 and June 2010 inspections. Your July 12, 2010 response indicates you where in the process of creating a lunch room for the employees. The November 13, 2012 response indicates you have addressed the observation by providing training to employees and by posting a sign explaining that eating and drinking is not allowed in production areas. This response is inadequate because your firm did not provide any evidence that employees were trained and that the sign was posted.
19) Your firm failed to handle equipment, containers, and utensils used to hold food in a manner that protects against contamination as required by 21 CFR 110.80(b)(7). Specifically, throughout the inspection employees were observed carrying glass jars in a manner that the interior of the jars came into direct contact with their gloved hands. Employees who were touching the interiors of the glass jars did not wash their gloves or change gloves prior to packing ready-to-eat products.
The November 13, 2012 response indicates employees were trained in proper procedures. This response is inadequate because you failed to provide any procedure and/or evidence that the employees have completed training.
20) Your firm failed to remove litter and waste that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant building or structures as required by 21 CFR 110.20(a)(1). Specifically, throughout the inspection, the dumpster lids were observed to be left open. The open dumpster was approximately twenty five feet from your ready-to-eat packing area. During the current inspection, the FDA investigator observed that the loading door to this area to be open throughout the inspection.
This is a repeat observation from the June 2010 inspection. Your July 12, 2010 response indicates you corrected this observation. The November 13, 2012 response indicates you covered the dumpster with a lid and moved the dumpster farther away. This response is inadequate because your firm failed to provide any evidence to show that the correction was implemented.
21) Your firm failed to take all reasonable precautions to ensure that production procedures do not contribute contamination from any source as required by 21 CFR 110.80. Specifically, on October 10, 2012, during the packing of sun-dried tomatoes in oil, a piece of cardboard was used to funnel soy oil into a five gallon bucket that was stored on the floor and that contained visible particulate matter. The oil was then poured from the same five gallon bucket into jars and used as the packing media for the ready-to-eat sun-dried tomatoes in oil finished products.
The November 13, 2012 response indicates that the issue was addressed and resolved by purchasing a spout. This response is inadequate because your firm fails to include the corrective procedures to address the filling operation such as appropriate storage, placement, and cleanliness of the utensils, e.g., buckets/containers/jars, used for filling ready-to-eat products.
The above list is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure that your establishment is in compliance with all requirements of the Act, the PHS Act and federal regulations. You should take prompt measures to correct all violations described in this letter. Failure to take appropriate corrective action may subject your firm and products to further actions, such as emergency permit control, injunction, or seizure.
You should notify this office in writing within fifteen (15) working days from your receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step taken to prevent their recurrence. In your response, include documentation of your corrective actions or steps towards long term corrective actions, such as evidence that you are working with a process authority or your scheduled process has been filed with the FDA, your HACCP plan, copies of your Sanitation Standard Operating Procedure, and other useful information or photographic evidence that would assist us in evaluating your corrections. If you cannot complete all corrective actions before you respond, we expect that you will explain the reason for your delay and state when you will correct the remaining deficiencies.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)).For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The July 2012 inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
Your written response should be sent to Dean R. Rugnetta, Compliance Officer, U.S. Food and Drug Administration, 622 Main Street, Suite 100, Buffalo, New York 14202. If you have any questions about this letter, please contact Compliance Officer Dean Rugnetta at (716) 846-6207 or E-mail at email@example.com
Ronald M. Pace
New York District
Peter Boboris, President
Sirob Imports, Inc.
515 Broadhollow Road
Melville, New York 11747