- On September 26, FDA announced the availability of two new chapters of the Draft Guidance for Industry: Hazard Analysis and Rick-Based Preventive Controls for Human Food. The two new
Consent Decree Entered Against Raw Animal Food Manufacturer
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- Yesterday, March 28, 2022, FDA announced that a New Jersey District Court has entered a consent decree of permanent injunction against Bravo Packing, Inc.,* a New Jersey animal food manufacturer,
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Consent Decree Entered for Real Water Hepatitis Outbreak
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- On June 1, the FDA published a press release announcing that Real Water Inc., a Nevada-based bottled water manufacturer, agreed to cease operations until they can comply with the Federal
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Supplement Manufacturer Gets Permanent Injunction
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- Dietary supplement manufacturer Confidence USA Inc., located in Port Washington, New York, its president, and its general manager received a permanent injunction on March 4, 2021 from the U.S. District
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FDA Enforcement Actions Following Findings in Food Facility Inspections of “Serious Violations” of CGMP Requirements in 21 CFR Part 117
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- We previously reported on FDA’s March 16, 2018 warning letter to Bhavani Fruits and Vegetables LLC for “serious violations” of Current Good Manufacturing Practice (CGMP) requirements under 21 CFR Part
FDA Finalizes Guidance on “Small Business” Definition under CGMP and Preventive Controls Regulations for Human and Animal Food
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- The FDA Food Safety Modernization Act’s (FSMA) Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-based Preventive Control (HARPC) provisions for human and animal food are implemented by
FDA Issues Draft Guidance on Produce Safety Requirements under FSMA
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- FDA has published two draft guidance documents to assist processors and farmers in complying with product safety requirements under the Food Safety Modernization Act (FSMA).
- The FSMA final rule on
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FDA Explains What to Expect As Compliance Date Nears for PC Animal Food Rule
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- On August 14, 2018, FDA released a constituent update regarding the upcoming compliance dates for the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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FDA Issues First Warning Letter for Alleged HARPC Violations
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- On July 26, 2018, FDA posted its first Warning Letter citing Kerry, Inc. for alleged violations of the Hazard Analysis and Risk-Based Preventive Controls (HARPC) and Current Good Manufacturing Practice
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FDA Survey of the Cosmetics Industry on Current Manufacturing Practices
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- The U.S. Food and Drug Administration (FDA) announced yesterday, July 2, 2018, an opportunity for public comment on a proposed survey of the manufacturing practices and standards employed across the
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