- Delivery Method:
- VIA UPS
- Food & Beverages
Recipient NameMr. Isaac Stern
Recipient TitleGeneral Manager
- Allied Food Products Inc
1600 West Elizabeth Avenue
Linden, NJ 07036-6325
- Issuing Office:
- Division of Human and Animal Food Operations East II
April 14, 2020
Dear Mr. Stern:
The United States Food and Drug Administration (FDA) inspected your acidified food and dry food mix manufacturing facility located at 1600 West Elizabeth Avenue, Linden, New Jersey, between February 12, 2020 through March 9, 2020. The inspection was initiated when testing conducted by New York State Department of Agriculture and Markets (NYSAGM) documented that some of the food products you produce are acidified foods for which you have not registered or filed a scheduled process with FDA. The products sampled by NYSAGM were “Garlic in Oil”, “Gravy Booster & Color”, “Glick’s Hot Sauce”, and “Deluxe Barbecue Sauce”. During that inspection we found that your firm had serious deviations from the Emergency Permit Control regulation (Title 21, Code of Federal Regulations, Part 108 (21 CFR 108) and Acidified Foods regulation (21 CFR 114).
At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations that lists the serious deviations found at the firm. We acknowledge the receipt of you written response, dated March 24, 2020, which included documentation describing corrections to the observations of concern noted on the form FDA-483. However, our evaluation of the documentation revealed that the response was not adequate, as further described in this letter.
Based on FDA’s inspectional findings and our assessment of your written response, we determined the acidified foods, including dressings and sauces, are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)1 in that it was prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth or rendered injurious to health.
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 good manufacturing practices. 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 Part 114.
The CGMP and PC rule, 21 CFR Part 117, includes updated CGMPs in subpart B with associated requirements for employee training and records in subparts A and F. Although not covered by this inspection, you also are subject to the preventive control requirements in the CGMP & PC rule (primarily located in subparts C and G). Under those requirements, a covered food facility must 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 the facility will not be adulterated under section 402 or misbranded under section 403(w) of the Act [21 U.S.C. § 342 and § 343(w)].
Further, a covered food facility must have a written food safety plan that includes a written hazard analysis and written preventive controls that are appropriate to the facility and food (i.e., process controls, food allergen controls, sanitation controls, recall plan, and a supply chain program as necessary). Other requirements include employee training (subpart A) and records (subpart F). Exemptions (21 CFR 117.5) and modified requirements (subpart D) are applicable to certain operations. As an acidified food processor, your food safety program should address the food safety hazard of Clostridium botulinum. You can find the Act, the Emergency Permit Control regulation, the Acidified Food regulation, and the CGMP and PC rule through links on FDA’s home page at www.fda.gov.
Your significant violations are as follows:
1. As a commercial processor engaged in the thermal processing of acidified foods, you must, no later than 60 days after registration and prior to the packing of a new product, provide the FDA information as to the scheduled process including conditions for heat processing and control of pH, salt, sugar, and preservative level, and source and date of the established process, for each acidified food in each container size, as required by 21 CFR 108.25(c)(2). However, our inspection revealed that you failed to file a scheduled process with FDA for your firm’s shelf-stable acidified products, including, but not limited to, Garlic in Oil; Hot Sauce; Gravy Booster & Color Sauce; Deluxe Barbecue Sauce; Sweet & Smoky BBQ Sauce; and Ranch, Italian, French, Thousand Island, Russian, Creamy Italian, and Caesar salad dressings. To date, you have not filed scheduled processes for your acidified foods.
Scheduled process information for acidified foods must be submitted on Form FDA 2541e (Food Process Filing for Acidified Method). More information on registration and filing can be found in the publication “Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in electronic or Paper Format” available at https://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/ucm309376.htm.
• Your response dated March 24, 2020, documents that you have communicated with a process authority. You provide a copy of the process authority’s letter, in which the process authority directs you to follow the regulations contained in 21 CFR 110. It should note that because of the size and operations at your facility, you are subject to 21 CFR 114 (Acidified Foods) and 21 CFR 117 (Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food Rule).
The letter from your process authority contains formulae and procedures with critical factors based on a scientific study2 for the following products: Hot Sauce, Garlic in Oil, French Dressing, BBQ Sauce, Salsa, Caesar Dressing, Smokey BBQ Sauce [sic], Thousand Island Dressing, Creamy Italian Dressing, Italian Dressing, Gravy Booster [sic], and Russian Dressing. You did not provide formulae for Deluxe Barbecue Sauce, Sweet & Smoky BBQ Sauce, and Ranch Dressing, so FDA is unable to evaluate these products at this time.
o The Agency has the following comments regarding the formulae provided in your response. It appears that the formulae don’t always match the critical factors referenced in the scientific study. For example, the scientific study specifies that to achieve a (b)(4) of (b)(4) in (b)(4), (b)(4) should be used in combination with (b)(4). Your formula for (b)(4), which is (b)(4), specifies the use of a different (b)(4), uses (b)(4) the study amount of (b)(4), and includes (b)(4) such as (b)(4) and (b)(4). Another example is your formula for (b)(4), which uses (b)(4), (b)(4), and includes (b)(4). These two formulae were chosen for examples only. You should examine all of your formulae critically to ensure they provide a scientifically-documented destruction of the vegetative cells of microorganisms of public health significance and those of non-health significance capable of growing in food.
o In addition, the documents you provided do not contain sufficient information to document that you will follow the study parameters of (b)(4) and (b)(4) (if applicable), (b)(4) (if applicable), (b)(4), and (b)(4) after the (b)(4). Also, you did not provide documents such as (b)(4), (b)(4), and (b)(4) calibrations to assure FDA that when you measure these critical factors, you will be doing so accurately.
2. You do not process acidified foods to an extent that is sufficient to destroy the vegetative cells of microorganisms of public health significance and those of non-health significance capable of growing in food in accordance with 21 CFR 114.80(a)(1). Specifically, your manufacturing and packaging processes for Garlic in Oil; Hot Sauce; Gravy Booster & Color Sauce; Deluxe Barbecue Sauce; Sweet & Smoky BBQ Sauce; and Ranch, Italian, French, Thousand Island, Russian, Creamy Italian, and Caesar salad dressings do not include a (b)(4). You also do not have documentation of the effectiveness of the (b)(4) used in these products, and do not conduct microbiological testing of these products for pathogens or spoilage organisms. In addition, these products are manufactured at (b)(4) and not labeled to be stored under refrigeration. Our Investigator observed that you do not take the initial pH of these products during the manufacturing process, and you do not document the pH of the product before packaging.
• Your response, dated March 24, 2020, includes copies of microbiological testing that you say was conducted “to confirm the effectiveness of [your] process.” You provided testing records for Hot Sauce, Garlic in Oil, Gravy Booster [sic], BBQ Sauce [sic], Salsa, Italian [sic], Tartar Sauce, and Thousand Island Dressing. All of these samples appear to have arrived at the lab on the same day, February 19, 2020. These samples, without more, are a snapshot in time that can be used as a verification step, but they are not a process validation and the Agency is unable to consider these results proof of correction.
3. Operators of processing and packaging systems are not under the operating supervision of a person who has attended and satisfactorily completed a school approved by the Commissioner in accordance with 21 CFR 114.10. Specifically, your employees do not manufacture acidified foods under the supervision of a person with appropriate training and experience in the acidification and processing of acidified foods. In addition, no one in your facility has attended a Better Process Controls course or any other approved FDA training in the manufacturing of acidified foods.
• Your response dated March 24, 2020 includes a copy of a training certificate for Better Process Controls School. Thank you for this submission. It will be documented as a correction.
4. You did not test and examine containers often enough to ensure that the containers suitably protected the food from leakage and contamination in accordance with 21 CFR 114.80(a)(4). Specifically, you did have evidence of examinations or testing of the integrity of the glass and plastic container-closure systems in which your acidified products are packaged.
• Your response, dated March 24, 2020, does not include written procedures, descriptions, or references that document how you plan to conduct container integrity and closure examinations. As such, the Agency is unable to evaluate your response to this observation. FDA may verify this correction during the next inspection.
5. Records are not maintained of the examination of finished products to verify compliance with FDA regulations and guidelines on action levels in accordance with 21 CFR 114.100(a). Specifically, our Investigator requested batch records from January 2019 to February 2020 for review. You only provided one batch record for each of the following products: Garlic in Oil, Hot Sauce, Gravy Booster & Color Sauce, and Caesar salad dressing. No batch records were provided for Ranch, Italian, French, Thousand Island, Russian, and Creamy Italian salad dressings. For the batch records that were provided, only the (b)(4) was documented. The batch records did not contain information for the (b)(4), (b)(4), or (b)(4) of the products. In addition, you did not provide records that document calibration of (b)(4) used to measure (b)(4) in your acidified products.
• Your response, dated March 24, 2020, includes an example batch records and written procedures, but does not include examples of completed records for the Agency to assess. As such, the Agency is unable to evaluate your response to this observation. FDA may verify this correction during the next inspection.
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.
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 Acidified Foods rule, and other applicable laws. In addition to compliance with 21 CFR 114 (Acidified Foods), you are required to comply with the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food Rule contained in Title 21, Code of Federal Regulations, part 117. More information, including Draft Guidance for Industry addressing this regulation can be found at: https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-preventive-controls-human-food.
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 the 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. In your response, you should include documentation, including revised procedures, photographs, results of tests you have conducted, and other useful information that would assist us in evaluating your corrections. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.
Your firm’s response should be sent to Compliance Officer Jessica D. Weber at United States Food & Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland, 21215. An emailed response is also acceptable. Files greater than 100 megabytes may be submitted as smaller files in separate emails. If you have questions regarding this letter, please contact CO Weber by telephone at (410) 779-5407, or by email at firstname.lastname@example.org.
Randy F. Pack
Acting Program Division Director and District Director
Human & Animal Food Division II East
Baltimore District Office
1 21 U.S.C. § 342(a)(4)