WARNING LETTER
Frozen Food Development, Inc.
MARCS-CMS 673836 —
June 21, 2024
Delivery Method:
VIA UPS
Product:
Food & Beverages
Recipient:
Recipient Name
Gary H. Gregory
Recipient Title
President
Frozen Food Development, Inc.
156 W. Harrisburg Avenue
Elizabethtown
,
PA
17570
United States
Issuing Office:
Division of Human and Animal Food Operations East II
United States
WARNING LETTER
CMS # 673836
June 21, 2024
Dear Mr. Gregory:
The United States Food and Drug Administration (FDA) inspected your individually quick frozen (IQF) packing and re-packing ready-to-eat (RTE) fruits and vegetables facility located at 156 W. Harrisburg Avenue, Elizabethtown, PA between October 10 and 13, 2023, and on November 30, 2023. 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).
Based on FDA’s inspectional findings, we have determined that the IQF RTE fruits and vegetables packed and re-packed in your facility 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 un-der insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive control 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 FDA’s regulations through links in FDA’s home page at http://www.fda.gov.
At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations, to Matt C. Rinehart, Operations Manager. We received your response sent via email on December 22, 2023, which included a summary of corrective actions you have taken or plan to take to address the observa-tions listed on the FDA-483. After reviewing the inspectional findings and the response your firm provided, we are issuing this letter to advise you of FDA’s concern and provide detailed information describing the findings at your facility. We also address your responses below.
Current Good Manufacturing Practice (21 CFR Part 117, Subpart B)
1. You did not take effective measures to exclude pests from your holding areas and to protect against contamination of food and food-packaging materials on the premises by pests, as required by 21 CFR Part 117.35(c).
Specifically, October 11, 2023, the FDA investigator observed evidence of rodent activity, including apparent rodent excreta pellets (REP) in numbers too numerous to count in the following areas of your facility:
On the floor and along the walls of the
(b)(4)
warehouse and related storage areas, where direct food-contact packaging materials (intended for frozen RTE produce) were stored.
On the floor in Freezers
(b)(4)
. In
(b)(4)
, exposed bulk chickpeas (lot #
(b)(4)
) were being held prior to being packaged. In Freezer
(b)(4)
, exposed RTE bulk strawberries (lot #
(b)(4)
) were being held prior to being packaged.
Along the wall in Freezer
(b)(4)
and within approximately
(b)(4)
inches of Market Basket Mixed Fruit (lot #
(b)(4)
), which was being stored, partially exposed, and awaiting use in production.
There was a previous FDA inspection conducted December 13, 2021 through March 7, 2022. That inspection also revealed failure to exclude pests from your facility, as evidenced by REPs and dead rodents.
In your written response, dated December 22, 2023, you stated that you plan to immediately clean up the REPs and dispose of affected products. You also stated that your facility had a pest problem in 2021 and that you retained a different pest company in early 2022, which has helped in “reducing the number of pests entering your facility”. You stated that this recent improvement is “reflected in your logs in the com-parison from the first FDA visit in 2021”. Additionally, gaps in the walls and other building damage contrib-ute to pests entering the facility. However, your response did not describe how you have or plan to exclude pests from accessing your facility going forward (such as making building repairs in response to the most recent inspection).
Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C)
2. You did not establish and implement a risk-based supply-chain program for those raw materials and other ingredients for which you have identified a hazard needing a supply-chain-applied con-trol, as required by 21 CFR 117.405(a)(1).
Specifically, your hazard analyses, dated January 18, 2023 and October 16, 2023, titled “Hayssen 1”, “Hayssen 2”, and “PPI”, for your frozen RTE produce indicate that pathogens are a hazard re-quiring a preventive control. The frozen RTE produce you receive is not treated to destroy patho-gens before leaving your facility. Your hazard analyses also indicate that pathogens on incoming frozen RTE produce will be controlled through “
(b)(4)
.” However, vegetative bacterial pathogens such as L. monocytogenes and Salmo-nella in RTE produce constitute a hazard that can cause serious adverse health consequences or death and thus annual onsite audit is the appropriate supplier verification activity unless there is a written determination that other verification activities and/or less frequent onsite auditing of supplier provide adequate assurance that the hazard is controlled (see 21 CFR 117.430(b)). The audit must be conducted before using the raw material or other ingredient from the supplier and at least annu-ally thereafter (see 21 CFR 117.430(b)(1)(ii)).
The previous FDA inspection conducted December 13, 2021 to March 7, 2021, similarly revealed failure to provide evidence that results of supplier audits were reviewed to verify control of vegeta-tive bacterial pathogens.
In your written response, dated December 22, 2023, you stated that you will review COA’s, Supplier Certificates and Supplier Audits to ensure control for pathogens in frozen RTE produce that you receive from your suppliers. However, you did not submit a revised hazard analysis or revised supply-chain program clarifying the specific supplier verification activities required for the vegetative bacterial pathogen hazard.
3. You did not identify and evaluate a known or reasonably foreseeable hazard to determine whether it is a hazard requiring a preventive control, as required by 21 CFR Part 117.130(a)(1).
Specifically, you did not identify and evaluate Cyclospora as a known or reasonably foreseeable hazard to determine whether it requires a preventive control in your frozen RTE berry products. Your hazard analyses titled “
(b)(4)
”, “
(b)(4)
”, and “
(b)(4)
” dated January 18, 2023, for pro-cessing frozen RTE produce (including berries) did not consider the parasite Cyclospora, which has been associated with frozen RTE berries. Oocysts of Cyclospora can be shed by infected hosts during harvesting. Depending on time and temperature, freezing may not be effective in ap-propriately destroying Cyclospora. Your berries are not treated to destroy pathogens before leaving your facility. A knowledgeable person processing food in your circumstances would identify Cyclo-spora as a hazard requiring a preventive control (i.e., supply-chain control) in the frozen RTE ber-ries you receive. Supply-chain controls include a supply-chain program as required by Subpart G of 21 CFR Part 117.
In addition, during the inspection, your quality manager stated that while reviewing audit results, she did not evaluate whether the audits specifically covered good agricultural practices and ade-quate water sources at the grower level [e.g., the most recent audit data for Healthy Frozen Inc (a freezing facility in Weston, FL from which you receive frozen RTE blackberries)]. You did not review Healthy Frozen Inc.’s supply-chain controls associated with the Cyclospora hazard at the farm.
The previous FDA inspection conducted December 13, 2021 through March 7, 2022, also revealed failure to identify Cyclospora as a known or reasonably foreseeable hazard to determine whether it requires a preventive control for frozen RTE berries.
During the most recent inspection, you provided an updated food safety plan dated October 16, 2023, concluding that Cyclospora is a hazard requiring a preventive control in the three hazard analyses noted above. In your written response, dated December 22, 2023, you stated that you added Cyclospora as a hazard in your food safety plan and that you will review COA’s, Supplier Certificates, and Supplier Audits. You also stated that you will review all audits, including the testing of water sources, to determine whether your suppliers are controlling Cyclospora. However, you did not include a revised supply-chain program in your updated food safety plan, nor did you submit one with your response. You also did not describe how you will verify control of practices and conditions to significantly minimize or prevent Cyclospora contamination of RTE berries at the grower level (e.g., effective hand washing; preventing human feces in latrines from entering the field through, for example, latrine tips and spills, or contamination of boots; worker health; and cleanliness of food-contact surfaces). Furthermore, you did not provide records demonstrating that you have implemented your corrective actions and have addressed employee training specific to these updates.
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to ade-quately address this matter may result in legal action including, without limitation, seizure, and injunction.
In addition to the violations described above, we offer the following comment:
We note that your food safety plan lists Norovirus as a known hazard for produce. However, your hazard analyses titled “
(b)(4)
”, “
(b)(4)
”, and “
(b)(4)
” dated October 16, 2023, for processing frozen RTE produce (including berries) did not evaluate whether viruses such as Norovirus and Hepatitis A require a preventive control. You should include viruses in your hazard analyses and determine whether they are a significant hazard in your frozen RTE produce.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any 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 actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your written response should be sent to Compliance Officer Melissa B. Libby at U.S. Food & Drug Admin-istration, 10 Waterview Blvd., 3rd Floor, Parsippany, NJ 07054. An emailed response is also acceptable. Files greater than 100 megabytes may be submitted as smaller files in separate emails. If you have ques-tions regarding this letter, please contact Melissa Libby by telephone at (973) 331-4997 or by email at melissa.libby@fda.hhs.gov.
Sincerely,
/S/
Robin M. Rivers
Acting Program Division Director
Baltimore District Office
Human & Animal Food East, Division 2
Office of Regulatory Affairs
U.S. Food and Drug Administration
randy.pack@fda.hhs.gov
Content current as of:
06/25/2024
Regulated Product(s)
Food & Beverages