- Delivery Method:
- Via Express Delivery
- Food & Beverages
Recipient NameMr. Kedar A. Bhat
Recipient TitleManaging Director
- K-Pra Foods Private Limited
1348 A V Bhat Co Building, Chimnya Ganapati
- Issuing Office:
- Center for Food Safety and Applied Nutrition
5001 Campus Drive
College Park, MD 20740-3835
Reference # 592680
Dear Mr. Bhat:
The U.S. Food and Drug Administration (FDA) inspected your acidified food (AF) facility, located at 1348 A V Bhat Co Building, Chimnya Ganapati, Pune, Maharashtra, 411030, India on June 10, 13 and 14, 2019. 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 Part 108) and the Acidified Foods regulation (21 CFR Part 114). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations that lists the observations made at your firm. We acknowledge receipt of your response received via email on July 8, 2019, which included documentation describing corrections to the observations of concern noted on the form FDA-483 as well as promised corrections. However, our evaluation of the documentation revealed that the response was not adequate, as further described in this letter.
As a manufacturer of acidified food products intended for export to the United States, you are required to comply with the Food, Drug and Cosmetic Act (the Act) and the regulations promulgated under the Act, including those relating to the processing of acidified food products. The Emergency Permit Control regulations were issued, in part, pursuant to section 404 of the Act, Emergency Permit Control, 21 U.S.C. § 344. A temporary emergency permit may be required for (b)(4) processed low-acid foods packaged in (b)(4) sealed containers and acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR 108.25, including registration and filing of process information, and the mandatory requirements in 21 CFR Part 114. Regulations specific to the processing of acidified food products are described in 21 CFR 108, and 21 CFR 114.
As outlined in the regulations, a commercial processor that does not adhere to all of the mandatory requirements of 21 CFR 108.25, and 21 CFR 114 could be subjected to an immediate application of the emergency permit control provisions of section 404 of the Act (21 U.S.C. 344). As stated in 21 CFR 108.25(j), for imported products, in lieu of issuing an order of determination that a permit is required before products from a commercial processor can be introduced into interstate commerce, FDA may take steps to refuse admission of the commercial processor's products under section 801 of the Act (21 U.S.C. 381) when offered for entry into the United States. Violation of the mandatory requirements set forth in 21 CFR 108.25, and 21 CFR 114 renders your acidified food products adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. 342(a)(4). You can find the Act and Acidified Food regulations through links in FDA’s home page at www.fda.gov.
Your significant violations are as follows:
1. You must file the scheduled processes with the FDA for each acidified food in each container size to comply with 21 CFR 108.25(c)(2). This filing must occur not later than 60 days after registration and prior to the packing of a new product and include conditions for heat processing; control of pH, salt, sugar, and preservative levels; and source and date of the establishment of the process, for each acidified food in each container size. Specifically, as noted during the inspection, your firm failed to file a scheduled process for your “Chilli Pickle” product. Your July 8, 2019 response states that you are in the process of filing the scheduled process. However, to date our office has not received your process filings for the “Chilli Pickle” you manufacture and ship to the United States.
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
2. Your firm did not provide evidence that the processes for the acidified food products that you manufacture were established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods, as required by 21 CFR 114.83. The inspection revealed the product is cured (b)(4) hours and then tested for (b)(4) and (b)(4) content and your firm does not monitor or test the (b)(4) of the finished product. However, your firm stated that this (b)(4)
In addition, you must have plant personnel involved in thermal processing systems, acidification, pH control, heat treatment, or other critical factors of the operation under the operating supervision of a person who has attended a school approved by FDA to comply with 21 CFR 114.10. We noted that during the inspection that no one at your firm has received training in critical factors in the production of acidified products, pH controls and critical factors in acidification.
Your July 8, 2019 response states that your Plant Head is a qualified person for the acidified foods and that you are in the process of identifying someone within 60 days. However, evidence of such training records has not been provided. We recommend that your firm work with a competent authority to develop and file the necessary scheduled processes for your acidified food operation.
You should respond in writing within (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. More specifically, your response should include documentation and information that would assist us in evaluating your corrections such as copies of your updated process filings and completed processing records demonstrating your firm’s ability to adhere to your scheduled process and monitoring of critical factors. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your imported acidified food products under section 801(a) of the Act (21 U.S.C. § 381(a)), including placing them on detention without physical examination (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the acidified food regulations (21 CFR 108 and 114) is Import Alert #99-38, Detention without Physical Examination of Low-Acid Canned Foods and Acidified Foods due to Inadequate Process Control. This alert can be found on FDA’s web site at https://www.accessdata.fda.gov/cms_ia/importalert_1132.html.
The Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule in Title 21, Code of Regulations Part 117 (21 CFR 117) (CGMP & PC rule) includes updated CGMPs in subpart B with associated requirements for employee training and records in subparts A and F. Your firm is also 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.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the AF regulations (21 CFR Parts 108 and 114) and the CGMP & PC rule (21 CFR 117). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Additionally, 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 reinspection-related costs. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for reinspection-related costs from the U.S. Agent for the foreign 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 reinspection-related costs. Please consider providing a copy of this letter to your U.S. Agent.
Please send your reply to the Food and Drug Administration, Attention: Marco S. Esteves, Compliance Officer, Food Adulteration Assessment Branch, Office of Compliance, Division of Enforcement, 5001 Campus Drive, College Park, MD 20740 U.S.A., or send via email at firstname.lastname@example.org.
If you have any questions regarding this letter, you may contact Marco S. Esteves via email at email@example.com. Please reference CMS 592680 on any submissions and within the subject line of any emails to us.
William A. Correll, Jr.
Office of Compliance
Center for Food Safety
and Applied Nutrition