FDA WARNING_LETTER - Joy Gourmet Foods LLC. - August 25, 2021
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The FDA issued a Warning Letter to Mr. Satish Parmar, Sales Manager & Co-Owner, for serious violations observed during an inspection of their ready-to-eat (RTE) acidified chutneys and pastes manufacturing facility at 48-80 Maspeth Ave., Maspeth, NY, from July 19, 2021, to August 25, 2021.
The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR part 117), and regulations for acidified foods (21 CFR part 108 and part 114). These violations render the acidified food products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 342(a)(4)].
Key violations include: - **Hazard Analysis and Risk-Based Preventive Controls (21 CFR 117.130(a), 117.135(a)(1), 117.145(a), 117.145(c)(1), 117.165(b)(1)):** Failure to conduct hazard analysis for allergens, chemical hazards (sulfites, Yellow #5), bacterial pathogens (
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