Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/k-pra-foods-private-limited-592680-10082019
Timestamp: 2019-11-14 12:25:24
Document Index: 688993031

Matched Legal Cases: ['art 108', 'art 108', 'art 114', '§ 344', 'art 114', 'art 117', '§ 342', '§ 343', 'arts 108']

K-Pra Foods Private Limited - 592680 - 10/08/2019 | FDA
K-Pra Foods Private Limited - 592680 - 10/08/2019
K-Pra Foods Private Limited MARCS-CMS 592680 — October 08, 2019
Mr. Kedar A. Bhat
1348 A V Bhat Co Building, Chimnya Ganapati
Reference # 592680
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.
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.
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.
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 marco.esteves@fda.hhs.gov.
If you have any questions regarding this letter, you may contact Marco S. Esteves via email at marco.esteves@fda.hhs.gov. Please reference CMS 592680 on any submissions and within the subject line of any emails to us.