- Delivery Method:
- VIA UNITED PARCEL SERVICE
- Food & Beverages
Recipient NameDavid Cotton
- Flying Food Group, LLC
212 N. Sangamon Street, #1A
Chicago, IL 60607
- Issuing Office:
- Division of Human and Animal Food Operations East III
60 Eight Street, NE
Atlanta, GA 30309
August 12, 2019
WARNING LETTER (#581977)
Dear Mr. Cotton:
The United States Food & Drug Administration (FDA) inspected your ready-to-eat (RTE) food manufacturing facility, located at 2000 Newpoint Parkway, Suite 800, Lawrenceville, GA 30043 from February 25 through March 6, 2019. During our inspection, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). FDA’s inspection resulted in the issuance of an FDA Form 483 (FDA-483), Inspectional Observations, listing deviations found during our inspection. We acknowledge your written responses to the FDA-483, dated March 18, 2019 and April 8, 2019, describing corrective actions taken by your firm. Based on our review of the inspectional findings and the responses that your firm provided, we are issuing this letter to advise you of FDA’s continuing concerns and to provide detailed information describing the findings at your facility.
During the inspection, FDA collected environmental samples (i.e., swabs) from various areas in your processing facility. FDA laboratory analyses of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility, including the same strain found during FDA’s 2018 & 2017 inspections. Based on FDA’s inspectional findings and the analytical results for the environmental samples, we determined that the RTE food manufactured in your facility is 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 it was prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health.
In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by section 301(uu) of the Act (21 U.S.C. § 331(uu)). You may find the Act and further information about the CGMP & PC rule through links in FDA’s home page at http://www.fda.gov.
Hazard Analysis and Risk-Based Preventive Controls (Subpart C):
1. Your hazard analysis did not identify a known or reasonably foreseeable hazard that requires a preventive control, as required by 21 CFR § 117.130(a)(1). Specifically, you did not appropriately evaluate environmental pathogens in accordance with 21 CFR § 117.130(c)(ii). You manufacture RTE foods that are exposed to the environment at several steps (e.g., meat slicing, produce cutting, batching, assemble product) where the food could be contaminated with environmental pathogens, such as L. monocytogenes, and the food does not receive a subsequent control for environmental pathogens. Your “FSQ 01-01, General Food Safety/HACCP Plan 080218” lists Sanitation Standard Operating Procedures (SSOPs) and a Listeria environmental monitoring program at (b)(4) and other processing steps where food is exposed to the environment, as reasons that a hazard (e.g., L. monocytogenes) is “not likely to occur.” However, for RTE foods exposed to the environment, SSOPs are sanitation controls that are verified by environmental monitoring. These controls should not be considered when determining whether sanitation preventive controls are needed. Environmental monitoring (e.g., your Listeria Environmental Monitoring Program (LEMP) FSQ 08-09) is needed to verify that environmental pathogens are being controlled by the sanitation control measures.
Furthermore, eleven environmental swabs collected by FDA during our most recent inspection were positive for L. monocytogenes. Of the eleven positive swabs, five swabs were collected from food contact surface areas, and six swabs were collected from areas adjacent to food contact surface areas. (According to your Plant Manager, food products manufactured during our environmental swabbing were discarded.) Furthermore, environmental swabs collected during our 2018 inspection revealed L. monocytogenes in three swabs within your facility, and environmental swabs collected during our 2017 inspection revealed L. monocytogenes in one swab within your facility. Whole genome sequencing (WGS) of isolates detected in the FDA environmental samples determined that the fifteen isolates collected during the 3 most recent inspections contain the same strain of L. monocytogenes. We advised you of those WGS results via a conference call on April 2, 2019. The presence of the same strain of L. monocytogenes over multiple years indicates that there has been a resident pathogen in your facility since 2017.
These findings demonstrate that your sanitation procedures have been inadequate to significantly minimize or prevent L. monocytogenes in your facility. Once L. monocytogenes is established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product. It is essential to identify the areas of the food processing plant where this organism is able to survive and grow to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the survival and growth of the organism and prevent the organism from being re-established in such sites.
You committed to performing corrective actions in written responses which we received on March 18, 2019 and April 8, 2019. In your written responses, you indicated that you have conducted refresher training for employees, performed intensified cleaning of all utensils, work surfaces, and equipment in the production batching and potwash areas, evaluated your current sanitation practices with your local chemical supplier, performed intensified swabbing for Listeria spp., implemented the “Re-sampling of the Environment after Obtaining a Positive Result” procedures, performed an internal audit of your firm’s sanitation and swabbing procedures, installed new storage mounts for sanitation utensils, (b)(4), and renovated the potwash room. We recommend that you identify potential harborage sites and source(s) of the organism in your processing environment and implement the necessary methods and controls to ensure the foodborne pathogen does not contaminate your RTE food products.
2. You are required to identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented, and the food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 or misbranded under section 403(w) of the Act (21 U.S.C. §§ 342 or 343(w)) to comply with 21 CFR § 117.135(a)(1). As evidenced by environmental findings that indicate a resident strain of L. monocytogenes in your facility, environmental pathogens are a hazard in your facility; your sanitation controls (i.e., your SSOPs) are not adequate to ensure that your facility is maintained in a sanitary condition to significantly minimize or prevent the hazard of the environmental pathogen L. monocytogenes, as required by 21 CFR §§ 117.135(a)(1) and (c)(3).
Current Good Manufacturing Practice (Subpart B):
1. You did not clean your utensils or equipment as frequently as necessary to protect against allergen cross-contact and contamination of food, as required by 21 CFR § 117.35(d). Specifically,
a. Exposed slices of meat were observed being stored on and in contact with the sides of a stainless-steel rack that contained visible debris.
b. Exposed single use food containers were observed stored inside crates that contained visible dirt and debris. The crates were inside the dry storage warehouse in the area designated for use in production and are not included in the equipment sanitation process.
2. You did not take reasonable measures and precautions to ensure that gloves used in food handling were maintained in an intact, clean, and sanitary condition, as required by 21 CFR § 117.10(b)(5). Specifically, employees were observed touching the sides of crates with visible debris without cleaning, sanitizing, or changing their gloves prior to handling bread slices used to make chicken & smoked bacon sandwiches.
The sanitation deficiencies and personnel practices described above are similar to the observations from the Agency’s February 5-7, 2018 inspection. Your firm appears to have taken steps to address the immediate sanitation concerns with the equipment during the inspection. However, we note that your response dated March 27, 2018 to our previous inspection also stated similar corrective action. As part of your 2018 response, you indicated that you would conduct re-training of the potwash and sanitation employees, have the FSQ technicians conduct increased monitoring of clean equipment during the pre-operational inspection, and have your chemical supplier conduct an audit to provide guidance on possible improvements. As evidenced from our current inspection and many repeat observations, your past corrective actions do not appear to have long lasting or effective results. We strongly encourage you to reassess and implement programs that are effective.
In reviewing the documentation collect during our inspection and your corrective action response, we have the following comments about your operation:
You did not identify undeclared allergens and allergen cross-contact as a known or reasonably foreseeable hazard requiring a preventive control. Your facility manufactures various products with different allergen profiles on the same day and on shared equipment. Your hazard analysis in “FSQ 01-01, General Food Safety/HACCP Plan 080218” considers allergens as potential chemical hazards at the (b)(4) and “(b)(4)” steps, indicating that allergens do not require a preventive control. Your justification that allergen hazards do not require preventive controls describes control measures for allergens, including an allergen management plan (Management of Allergens document FSQ 04-15). Your allergen management plan controls should not be considered when determining whether allergen preventive controls are needed.
Adding antimicrobial substances to wash water is a preventive control to significantly minimize or prevent pathogen cross-contamination during washing of leafy vegetables and conveying leafy vegetables in water-based systems such as flumes. You have indicated that such washing/sanitizing is done by suppliers or inhouse. When done by suppliers, a supply-chain program would be required. In addition, for RTE produce that does not have a kill step, you should evaluate the need for a supply-chain program that addresses growing/harvesting by farms, which may be your suppliers or your supplier’s supplier. You stated that you require suppliers to be audited (b)(4) or submit GFSI certifications (b)(4). When a hazard is controlled prior to receipt and an audit is used for supplier verification, 21 CFR 117.435 specifies that an onsite audit must consider applicable FDA food safety regulations and include a review of the supplier's written plan (e.g., HACCP or other food safety plan), if any, and its implementation, for the hazard being controlled.
In addition, to control pathogen growth and or toxin formation due to a lack of time and temperature control during distribution, it is important to consider the significance of these hazards in your process and to determine whether or not a preventive control during distribution is required for food safety.
This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for ensuring that your facility operates in compliance with the Act, the CGMP & PC rule, and other applicable laws. You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by the FDA without further notice, including, without limitation, seizure and injunction.
Section 743 of the Act, (21 USC 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 non-compliance 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 USC 379j-31(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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please notify this office in writing within fifteen (15) working days of your receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. In your response, you should include documentation, including revised procedures, photographs, results of tests you have conducted, and other useful information that will assist us in evaluating your corrections. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Your written response should be sent to Janice L. King, Compliance Officer, U.S. Food and Drug Administration, 4600 Goer Drive, #106, North Charleston, SC 29406. If you have any questions about this letter, please contact Ms. King at (843) 746-2990 x16 or via email at firstname.lastname@example.org.
Ingrid A. Zambrana
Program Division Director
Office of Human and Animal Foods
Division East III (Georgia, North Carolina, and South Carolina)
Office of Regulatory Affairs
U.S. Food and Drug Administration
Michael Lal, General Manager
Flying Food Group, LLC
2000 Newpoint Parkway, Suite 800
Lawrenceville, GA 30043
Natalie Adan, Division Director
Food Safety Division
Georgia Department of Agriculture
19 Martin Luther King, Jr. Dr. S.W.
Atlanta, GA 30334