- Preferred Meal Systems, Inc.
- Issuing Office:
- Philadelphia District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||PHILADELPHIA DISTRICT|
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
VIA OVERNIGHT MAIL
February 12, 2016
Mr. George Chivari
President & Chief Executive Officer
Preferred Meal Systems
5240 St. Charles Road
Berkeley, Illinois 60163
Dear Mr. Chivari:
The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE), cold cut sandwiches and boxed lunches and non-RTE, cooked frozen entrees and side dishes manufacturing facility, located at 4135 Birney Avenue, Moosic, PA, between August 4, 2015 and September 2, 2015. During our inspection, FDA investigators collected an environmental sample consisting of multiple swabs taken from various areas within your processing facility. FDA laboratory analyses of the environmental swabs found the presence of a human pathogen Listeria monocytogenes (L. monocytogenes) in your facility. Additionally, FDA investigators observed serious violations of the Current Good Manufacturing Practice in Manufacturing, Packing or Holding Human Food (CGMP) regulation, Title 21, Code of Federal Regulations, Part 110 (21 CFR part 110) and the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR part 123). Based on FDA’s analytical results of the environmental sample and inspectional findings documented during the inspection, we have determined that your 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 they were prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health. You can find the Act and FDA’s regulations through links on FDA’s home page at http://www.fda.gov.
This inspection resulted in FDA’s issuance of a Form FDA-483, Inspectional Observations (FDA-483), at the conclusion of the inspection. We acknowledge your firm’s September 23, 2015, response to the FDA-483, which includes a description of corrections to the observations of concern noted on the FDA-483. However, your response does not provide comprehensive information to ensure the adequacy of your corrective actions in addressing the violations observed during the inspection.
On August 4, 2015, FDA investigators collected an environmental sample (INV 891229), which consisted of a total of (b)(4) swabs/subs, from the Airline Production Room of your facility. FDA laboratory analysis of these subs confirmed the presence of L. monocytogenes in (b)(4) subs, as follows:
- Sub 7 – Floor under tomato sauce filler Co-pack (b)(4) line of the Airline Production Room.
- Sub 14 – Square shaped hole in the floor near the end of the wall of the Airline Production Room.
- Sub 23 – Bottom of the red shovel stored against the wall of the Airline Production Room.
- Sub 33 – Floor drain from the Airline Production Room.
- Sub 41 – Floor near the roll up door to the dock area of the Airline Production Room.
In addition, on August 6, 2015, our investigators collected environmental sample (INV 891230), which consisted of a total of (b)(4) subs, from areas in the School Lunch Program Room of your facility. FDA laboratory analysis of these subs confirmed the presence of L. monocytogenes in three (3) subs, as follows:
- Sub 131 – Sponge part of blue squeegee stored against wall near start of Co-pack 2 line.
- Sub 137 – Wheel of the tomato sauce hopper on Co-pack (b)(4) line.
- Sub 149 – Yellow metal 2-step stool.
The presence of Listeria monocytogenes in your facility is significant in that it demonstrates the sanitation efforts are inadequate to effectively control pathogens in your facility to prevent contamination of food. L. monocytogenes is a pathogenic bacterium that can contaminate foods, resulting in a mild illness called listerial gastroenteritis or a severe, sometimes life-threatening, illness called invasive listeriosis. Immune-compromised individuals, the elderly and unborn fetuses are particularly susceptible to listeriosis. L. monocytogenes differs from most other foodborne pathogens because it is widely distributed, resistant to diverse environmental conditions, and grows under refrigeration conditions. You should take steps to identify and control this organism in your facility to ensure food does not become contaminated.
On August 27, 2015, FDA informed you of these results. FDA acknowledges your written response to the FDA form 483, Inspectional Observations, on September 23, 2015. However, your response is inadequate. Your response does not provide details of the corrective actions taken where all of the positive swabs were collected in your facility, including subs 131, 137, 149. In addition, your response includes fourteen Certificates of Analyses for environmental swabs collected for Listeria monocytogenes from your facility, all with negative results. The results do not specify the location in the facility where the swab was collected; i.e., whether the swabs were collected from food contact equipment or from the same locations as the positive FDA swabs.
FDA investigators also observed the following significant violations of the Current Good Manufacturing Practice (CGMP) regulation [21 CFR Part 110]:
1. You must conduct the manufacture, including package, and storage, of foods under such conditions and controls as are necessary to minimize the potential for growth of microorganisms, or for the contamination of food, as required by 21 CFR 110.80(b)(2). However, in the Airline Production Room, our investigators observed:
a. An employee was using a high pressure hose to clean the side of the Co-pack (b)(4) line. The water from the hose was observed aerosolizing into the air in close proximity to the Airline (b)(4) line while it was processing cheese tortellini with sauce, approximately (b)(4) feet away.
We acknowledge your September 23, 2015 response that your firm has implemented a new training procedure, but the documentation provided is inadequate in that it does not provide detailed information regarding when and how high pressure washing should be implemented and monitored such that the use of these high pressure hoses during production do not contribute to cross contamination from the processing environment to the food.
2. You must construct, handle, and maintain equipment, containers, and utensils used to convey, hold, or store raw materials, work-in-progress, rework, or food during manufacturing or storage in a manner that protects against contamination, as required by 21 CFR 110.80(b)(7). However, our investigators observed:
a. A stainless steel plate covering a metal cart had bulging sections on the center edges and corner edges that were not in contact with the table portion of the cart. This created a gap which could allow for food particles and debris to become trapped and accumulate under the stainless steel plate, which could lead to contamination of food/growth of microorganisms in the finished food products.
We acknowledge your September 23, 2015 response which includes monitoring the tables and carts for sanitation and rotating the tables out of production as new tables arrive at your facility. However, your response did not provide completed corrective action/sanitation monitoring documentation for the sanitation and inspection of the current tables in use in production areas for review by FDA.
3. You must handle work-in-process in a manner that protects against contamination, as required by 21 CFR 110.80(b)(5). Specifically, on August 10, 2015, you were manufacturing Pineapple Fruit Cups Product Code (b)(4), Lot Number (b)(4). Our investigators observed water leaking from the pipe directly above the large tank, down the yellow shut off handle and directly into the large tank and onto in-process pineapple in your Clarity Room (Fruit Cup Line). Water leaking directly into in process food products, in particular ready-to-eat foods, may contribute to contamination of your in-process and finished food products.
We acknowledge your September 23, 2015 response to the FDA form 483 however, your response is inadequate for the following reasons: First, your response states that if condensate is noted in the plant, a determination will be made to stop the line and hold product; however, your Preferred Meals “Condensation Mopping SOP” does not include a section stating that a food production line must stop and hold product if your facility determines there is a deviation from the “Condensation Mopping SOP”. Second, your condensation SOP provides instructions for cleaning condensate from the production room ceiling in the event condensate is identified; however, the SOP does not address the sanitation or protection of food contact equipment in the event condensate is observed dripping from the ceiling onto food contact equipment.
4. All persons working in direct contact with food, food-contact surfaces, and food-packaging materials must wash their hands thoroughly and sanitize if necessary to protect against contamination with undesirable microorganisms in an adequate hand-washing facility before starting work, after each absence from the work station, and at any other time their hands may have become soiled or contaminated, as required by 21 CFR 110.10(b)(3). Specifically, on August 4, 6, and 10, 2015, our investigators observed in the School Lunch Program Room:
a. More than a (b)(4) employees entered the production room from the employee break room/locker room without washing their hands.
b. Employees were entering the production room from the employee break room/lunch room, failed to use soap when washing their hands and only rinsed their hands with water. This also included a female employee who was instructed by the Quality Manager to remove her nail polish and upon her re-enter to the production room, only rinsed her hands.
c. An employee, after washing her hands, was touching her face and nose without re-washing her hands.
d. An employee who had just washed her hands was observed helping another female employee fix her hoodie under her smock. This employee did not re-wash her hands after touching the other employee’s clothing.
e. A female employee entering the production room, from the employee break room/locker room area, walked past the hand washing sink without washing her hands. Another female employee yelled to the employee to wash her hands; however, the female employee waved her hand in the air and continued walking to the Airline Production Room.
At the close of the inspection, you stated that you plan to address traffic patterns within the plant. Your September 23, 2015 response states you have implemented refresh GMP training, hand washing signs, and daily audits for monitoring employee hygiene, however, your response did not address employee/equipment traffic patterns that may contribute to contamination. We recommend a more robust sanitation plan in terms of employee hygiene monitoring, maintenance of personal protective equipment, and traffic patterns between employees and equipment in the plant to prevent possible cross contamination with processing areas of the firm.
5. You must have hand-washing facilities that are adequate and convenient and furnished with running water at a suitable temperature, as required by 21 CFR 110.37(e). Specifically, the hand sink in the Blending Room was at a cold temperature and did not reach a suitable
temperature for hand washing until approximately 1 minute.
6. You must construct the plant and facilities in such a manner that floors, walls, and ceilings may be kept adequately cleaned and kept clean and kept in good repair; that drip or condensate from fixtures, ducts, and pipes does not contaminate food, food-contact surfaces, or food packaging materials; and that aisles or working spaces are provided between equipment and walls and are adequately unobstructed and of adequate width to permit employees to perform their duties and to protect against contaminating food or food-contact surfaces with clothing or personal contact, as required by 21 CFR 110.20(b)(4). Specifically, our investigators observed:
a. In the doorway between the Airline Production Room and the Clean Room, there is a gap between the ceiling and the wall stainless steel plate that was installed. We acknowledge that you informed our investigators at the close of the inspection that the maintenance department is working on fixing the gaps/cracks in various areas of the firm; however, this was not verified at the close of the inspection.
b. There are numerous processing areas with peeling floor paint and deteriorated areas of flooring. The deteriorated areas of flooring were no longer smooth or cleanable, and left the concrete exposed with water accumulating on the concrete and under the remaining floor surrounding these areas.
c. There are also a number of areas where the walls of the facility were deteriorating. In particular: In the Lycos Room there is one section of wall, located near the fire extinguisher, that had chipped and peeling paint. And another section of wall located by the conveyor (used to move cooked product as it exits the Lycos cooker) had chipped/missing paint. Additionally, the walls in the short hallway between the Lycos Room and the Kitchen/Kettle Room had missing and chipped paint.In the School Lunch Program Room there was a section of wall missing and was covered with a stainless steel plate. The plate did not cover the entire missing section of the wall. The bottom two corners of the area were open and exposed.
We acknowledge your September 23, 2015 response to the FDA form 483 however; the response does not adequately address the floor, standing water, gaps in the wall between the Airline Production Room and Clean Room and sanitation practices used in the various production areas of the firm. Your response states you repaired the floor in the Airline Room only, but your response does not adequately address all the other floors throughout your processing facility that need to be repaired.
Additionally, FDA investigators also observed the following significant violations of the Seafood HACCP regulation [21 CFR Part 123]:
7. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and to identify the preventive measures that you can apply to control those hazards (a HACCP plan) that, at a minimum, lists the food safety hazards that are reasonably likely to occur and that thus must be controlled, as required by 21 CFR 123.6 (a) and (c) (1). A food safety hazard is defined in 21 CFR 123.3 (f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm’s HACCP plans for RTE (ready-to-eat) and NRTE (not ready-to-eat) Fish and Fishery Products do not list the food safety hazards of histamine formation (associated with the tuna products you produce) and undeclared fish allergens.
8. You must have a HACCP plan that, at a minimum, among other requirements, lists the procedures, and frequency thereof, that will be used to monitor each critical control point to ensure compliance with the critical limits, as required by 21 CFR 123.6 (c) (4). However, your firm’s HACCP plan for RTE and NRTE Fish and Fishery Products lists a monitoring procedure and frequency at the Storage in cooler critical control point that is not adequate to control pathogen growth and toxin formation, including Listeria monocytogenes growth. FDA recommends that you monitor the ambient air temperature of the cooler using a continuous temperature-recording device (e.g., a recording thermometer) with continuous monitoring by the device itself and a visual check of the recorded data at least once per day.
9. You must have a HACCP plan that, at a minimum, among other requirements, lists the critical control points for each of the identified food safety hazards, as required by 21 CFR 123.6 (a) and (c) (2). A critical control point is defined in 21 CFR Part 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However, your firm’s HACCP plan for RTE and NRTE Fish and Fishery Products does not list the critical control point(s) of:
a. Receiving for controlling the food safety hazard of pathogen growth and toxin formation, including Listeria monocytogenes growth, that is reasonably likely to occur in the Pre-Made Tuna Salad you receive. For fish or fishery products delivered refrigerated (not frozen), FDA recommends that all lots received are accompanied by transportation records that show that the product was held at or below an ambient or internal temperature of 40°F (4.4°C) throughout transit.
b. Unrefrigerated Processing (including mixing of tuna ingredients and assembly of sandwiches and lunch boxes) for controlling the food safety hazard of pathogen growth and toxin formation, including Listeria monocytogenes growth, that is reasonably likely to occur in the tuna salad sandwiches you produce. For cooked, ready-to-eat products, FDA recommends that the product is held at internal temperatures below 50°F (10°C) throughout processing or that the product is held at ambient air temperatures below 50°F (10°C) throughout processing. However, you also should consider other hazards that are reasonably likely to occur, such as histamine formation, when establishing a critical limit for unrefrigerated processing.
10. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, as required by 21 CFR 123.7(b). However, your corrective action plan for RTE and NRTE Fish and Fishery Products at the Storage-in cooler critical control point to control pathogen growth and toxin formation, including Listeria monocytogenes growth, is not appropriate to control pathogen growth and toxin formation. The corrective action plan should list the specific predetermined corrective actions that will be taken when a deviation from the critical limit occurs and to assign responsibility for taking those actions to ensure that no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation and to ensure that the cause of the deviation is corrected. Because you chose to monitor the Storage-in cooler, FDA recommends that you consider amending your corrective action plan to state that the following actions should be taken whenever there is a deviation from a critical limit.
a. Chill and hold the affected product until an evaluation of the total time and temperature exposure is performed. A product with cumulative exposures that exceed the critical limits should be cooked or diverted to a use in which the critical limit is not applicable (e.g., divert crabmeat to a stuffed flounder operation), after giving consideration to the fact that any S. aureus or B. cereus toxin that may be present may not be inactivated by heat, or destroyed or diverted to a non-food use; OR
b. Cook the product, after giving consideration to the fact that any S. aureus or B. cereus toxin that may be present may not be inactivated by heat; OR
c. Divert the product to a use in which the critical limit is not applicable (e.g., divert crabmeat to a stuffed flounder operation), after giving consideration to the fact that any S. aureus or B. cereus toxin that may be present may not be inactivated by heat; OR
d. Destroy the product; OR
e. Divert the product to a non-food use. AND
f. Move some or all of the product in the malfunctioning cooler to another cooler; AND
g. Make repairs or adjustments to the malfunctioning cooler.
The inspectional observations, identified above, are not intended to be all-inclusive of the conditions observed at your facility and the violations that may exist with respect to your products. It is your responsibility to ensure adherence with all requirements of the applicable regulations for your Airline Production Room and any other conveyances or facilities involving interstate travel and sanitation under your control. And, you are also responsible for ensuring compliance with the FD&C Act and all applicable implementing regulations. You should take prompt action to correct all of the violations noted in this letter and to implement procedures to prevent such violations from recurring. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
In addition to the above violations, based on our review of your HACCP plan for RTE and NRTE Fish and Fishery Products (effective January 31, 2015), we have the following comment:
Your firm’s HACCP plan for RTE and NRTE Fish and Fishery Products includes references to the U.S. Department of Agriculture’s (USDA’s) regulations for meat and poultry products. USDA’s regulations do not apply to the seafood products you produce. You should ensure that the seafood products you produce are processed in accordance with FDA regulations, which can be found in Title 21 of the Code of Federal Regulations.
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 re-inspection-related costs. A re-inspection 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. Re-inspection-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 re-inspection fees (21 U.S.C. 379j-1(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The 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 re-inspection-related costs.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations. Please also include documentation or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, please explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to the Food and Drug Administration, Attention: Lynn S. Bonner, Compliance Officer, 900 U.S. Customhouse, 2nd & Chestnut Street, Philadelphia, PA 19106. If you have questions regarding any issues in this letter, please contact Ms. Bonner at 215-717-3074 or you can email her at email@example.com
Anne E. Johnson
Acting District Director
cc: Robert C. Carlson, VP of Technical Services
Preferred Meal Systems
5240 St. Charles Road
Berkeley, Illinois 60163
Mr. Mark Holmes, Director of Operations
Preferred Meal Systems, Inc.
4135 Birney Avenue
Moosic, PA 18507
Pennsylvania State Department of Agriculture
Bureau of Food Safety and Laboratory Services
Attention: Dr. Lydia Johnson, Director
2301 North Cameron Street
Harrisburg, PA 17110-9408
United States Department of Agriculture
Food Safety Inspection Service
Attention: Susan Scarcia, District Manager
Mellon Independence Center
701 Market Street, Suite 4100A
Philadelphia, PA. 19106