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FDA Issues First Warning Letter Based on “Serious Violations” of Part 117 CGMP Regulations

Posted on March 30, 2018
  • On March 16, 2018, FDA issued a warning letter to Bhavani Fruits and Vegetables LLC in Maspeth, New York for “serious violations” of Current Good Manufacturing Practice (CGMP) requirements under

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Continue Reading FDA Issues First Warning Letter Based on “Serious Violations” of Part 117 CGMP Regulations

FDA Releases Guidance Documents Concerning Animal Food CGMPs and the FSMA “Solely Engaged” Exemptions

Posted on October 19, 2017
  • As previously covered on this blog, the Final Rule for Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals, 80 Fed. Reg. 56170

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Continue Reading FDA Releases Guidance Documents Concerning Animal Food CGMPs and the FSMA “Solely Engaged” Exemptions

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