US: Flying Food Group, Inc. 1/20/12 - Warning letter and notice of provisional status
Posted: February 17th, 2012 - 10:18pm
Ms. Sue L. Gin, Chief Executive Officer
Flying Food Group, Inc.
212 North Sangamon St.
Chicago, IL 60607
File No.: 12-NWJ-08
Dear Ms. Gin:
This letter serves as your formal notification that the U.S. Food and Drug Administration (FDA) has changed the classification of your airline catering facility from “Approved” to “Provisional.” Your airline customers will be notified of this change in classification. Between July 18, 2011 and August 1, 2011, FDA conducted an inspection of your airline catering facility located at 640 Frelinghuysen Avenue, Newark, NJ. This inspection was conducted under the authority of the Public Health Service Act (PHS Act) to determine your compliance with applicable sections of the Interstate Conveyance Sanitation regulations (21 CFR Part 1250). These regulations were promulgated pursuant to Section 361 of the PHS Act (42 USC § 264). Regulations promulgated under this section are necessary to prevent the introduction, transmission, or spread of communicable diseases. This inspection revealed significant violations of 21 CFR Part 1250 under the PHS Act. Based on these findings, your airline catering facility is classified as "Provisional."
In addition, you firm operates as a contract sandwich manufacturer and manufactures ready-to-eat tuna fish sandwiches subject to the Seafood HACCP regulations. Our investigators found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan to comply with this section or otherwise operate in accordance with the requirements of 21 CFR 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), Title 21, United States Code, Section 342(a)(4). Accordingly, your seafood products are adulterated, because they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
We acknowledge your written response dated August 11, 2011, received by New Jersey District on August 18, 2011, to the FDA 483 issued to your firm at the close of the inspection on August 1, 2011. However, as discussed further below, your response did not adequately address the violations observed during the inspection.
Interstate Conveyance Sanitation regulations
The following are the violations observed during the inspection on which we base the “Provisional” classification:
You did not keep all perishable food at or below 50°F except when being prepared or kept hot for serving, as required by 21 CFR 1250.27. For example, on July 19, 2011 between 11:30 am and 1:00 pm the investigators observed that the Hot Food Cooler #1 used to store potentially hazardous foods had an ambient temperature of 50.5°F. Stored in this cooler was Norica, a beef and cheese entree, which began the cooling process at 9:34 am, and was 128.3°F when measured by investigators.
Your firm’s response to the inspection states that the temperature deviations were related to the blast chiller not operating and “the system needing more Freon.” You state that the refrigeration mechanic “added Freon and cleaned the condensers,” but it is unclear from your response whether your blast chiller and refrigeration units are now operating properly. Your response is also inadequate because it did not provide any documentation to support that the stated corrective actions were performed. We acknowledge that during the inspection firm management voluntarily destroyed some of the food items listed above; however, that does not address the underlying cause of the temperature violations at your facility.
Your food handling operations were not conducted in a manner that minimizes the possibility of contaminating food, drink, or utensils, as required by 21 CFR 1250.32(a). For example:
Condensation was observed on the cooler units of the (b)(4)/Cold production room directly above food preparation areas and finished products such as plates of cheese and nuts.
Condensation was observed on the drop ceiling and the cooler units in the entrée pack room over salad greens in perforated bags and single service articles such as plastic forks and small plastic cups.
Your firm’s response to this violation is inadequate because it does not address the underlying cause of the condensation on the ceiling tiles, or provide the steps you will take to prevent the condensation from recurring.
Plumbing was not adequately maintained to prevent contamination of food and food utensils, as required by 21 CFR 1250.30(d). Specifically, the floor drain that the pot wash sink indirectly drains into was clogged and the waste water from the sink was draining onto the floor. Waste water was also leaking from a pipe onto the floor. Employees were observed stepping into the waste water and tracking it into the kitchen which is directly adjacent to the pot wash room.
Your firm’s response to the inspection stated that you have addressed the above violation, however your response was inadequate because you did not provide documentation such as photos to demonstrate that the stated corrective action was taken.
Not all utensils used in the connection with the preparation of food are maintained in good repair, as required by 21 CFR 1250.33(a). Specifically, several cutting boards in the hot kitchen and the hot kitchen prep area were stained and had gouges.
Your firm’s response states that all scarred boards will be replaced immediately with back-up stock that is in the facility. Because this was not completed as of the date of the response and your response did not provide documentation such as photos that the stated corrective action was taken, your response was inadequate.
Please be advised that FDA has recently published a 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance (i.e. the Hazard Guide).
Your significant violations of the seafood HACCP regulation were as follows:
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 have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 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 plan for tuna sandwiches and tuna bistro box snack plates does not list the food safety hazard of histamine formation.
The HACCP plan that you provided with your response does not list the hazard of histamine formation. Your response indicates that “Histamine is a chemical and manufacturers guarantee states that they conduct test and release for histamine. Histamine is screened out at the manufacturing level. In plant histamine exposure is not possible without re-inoculation of the product with the chemical or the specific bacteria that cause the histamine.” However, your response is inadequate because tuna is a scombroid species of fish and histamine can form via re-introduction of the scombrotoxin-forming bacteria during salad-making operations (e.g., contact with employees hands or introduction of raw ingredients). Further, FDA considers the potential for histamine formation to be reasonably likely as a result of time and temperature abuse at your facility. Controls for that hazard should be in place during and after that processing step.
You chose to include a corrective action plan in your HACCP plan. To comply with 21 CFR 127.3(b), an appropriate corrective action plan will describe the steps to be taken to ensure that no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation. However, your corrective action plan for tuna sandwiches and tuna bistro box snack plates at the “unpack/drain tuna,” “prepares tuna salad batches,” “refrigerate prepared tuna,” “assemble product,” and “final hold” critical control points to control pathogen growth and histamine formation are not appropriate. Specifically, your corrective action plan states if the temperature is (b)(4) for more than (b)(4), the Chunk White Albacore Tuna product will be moved to a (b)(4), the internal temperature of the Chunk White Albacore Tuna product shall be taken, and the internal temperature monitored (b)(4) until the internal temperature is ≤ (b)(4) within (b)(4), or then destroyed. Acceptable exposure times are dependent upon the internal temperature of the product and the pathogen of concern. Your current corrective action plan would permit tuna to be held at ambient temperatures above (b)(4) for up to (b)(4) before the product is destroyed. At temperatures above (b)(4), pathogen growth in your tuna and tuna sandwiches can reach levels of public health concern.
Although your response stated that you are working with a consultant to ensure compliance, your response is inadequate because you did not provide documentation of any correction.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Based on the violations of the Interstate Conveyance Sanitation regulations observed during the inspection, a "Provisional" classification has been assigned to your airline catering facility for a 30 day period, after which time a re-inspection will be conducted. A "Provisional" classification means that the facility may continue to operate; however, significant correction of violations must be made. If these violations are not improved and verified by FDA by the time of the next inspection, then your facility will be classified as "Use Prohibited" or "Not Approved." Airlines engaged in interstate traffic may not obtain their food from a "Use Prohibited" or "Not Approved" source.
Please also note that your manufacturing records, including your Hand-Over CCP #2 forms and your (b)(4)Daily Production sheets, do not contain the time designations of A.M. or P.M. Since your establishment is open 24 hours a day, and 7 days a week, we recommend you include these designations to clarify when monitoring and recordkeeping activities are performed.
Further, please note that employees who were responsible for verifying and documenting final product temperatures did not have thermometers to measure food temperatures and could not provide dispatch log records where final temperatures are taken. We recommend that you ensure that thermometers are readily accessible to employees and that you ensure that temperature logs are accurate and up-to-date.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Your response should be addressed to U.S. Food and Drug Administration, 10 Waterview Boulevard, 3rd Floor, Parsippany, New Jersey, 07054, Attn: Kerry Kurdilla, Compliance Officer.
New Jersey District
Flying Food Group, Inc
640 Frelinghuysen Ave.
Newark, NJ 07114