As part of its enforcements, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent.
Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.
K-Pra Foods Private Limited
Pune, Maharashtra, India
The Food and Drug Administration sent a warning letter dated Oct. 8 to Kedar Bhat, the managing director of K-Pra Foods Private Ltd.
U.S. inspectors found serious deviations from the Emergency Permit Control regulation and the Acidified Foods regulation at K-Pra Foods Private Ltd. acidified food facility in Pune, Maharashtra, India. In response to these deviations, the FDA issued an FDA-483, Inspectional Observations that lists deviations observed at the facility. Though located in India, as a manufacturer of acidified food products intended for export to the United States, K-Pra Foods Private Limited is required to comply with the U.S. Food, Drug and Cosmetic Act.
The violations noted by the FDA include:
- “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.”
- “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 (redacted) hours and then tested for (redacted) and (redacted) content and your firm does not monitor or test the (redacted) of the finished product. However, your firm stated that this (redacted)”
- “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.”
A complete list of the violations in the FDA warning letter.
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