• 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 117.  This is believed to have been the first time FDA formally cited Part 117 CGMP regulations promulgated under FSMA in a warning letter (as opposed to Part 110 CGMP regulations that preceded FSMA).  The old food CGMP regulations (21 CFR Part 110) were modernized under Part 117 to, among other things, make education and training of food workers mandatory, make explicit that CGMP regulations encompass allergen cross-contact, and include provisions for holding and distribution of human food by-products that are used for animal food.
  • September 17, 2018, which is the date when very small businesses were required to comply, was the latest of the staggered compliance dates for food facilities to meet all requirements of the revised CGMP regulations.  Since that time, FDA has typically posted at least two warning letters each month that cite to serious violations of 21 CFR Part 117.  Ready-to eat foods, including baked goods, ice cream, and tahini, are the products most often mentioned in FDA’s warning letters for CGMP violations.  Plant construction issues, such as poor drainage, along with pest problems (i.e., rodents and insects) are the most frequently cited violations.  Many of the most recent warning letters for CGMP violations involve environmental findings for Listeria monocytogenes, such as a November 22, 2019 warning letter to Friendly’s Manufacturing and Retail, or failure to protect against allergen cross-contact, such as an October 9, 2019 warning letter to Pollman’s Bake Shops.
  • While some of FDA’s warning letters cite to CGMP training and education deficiencies, to date we do not believe the Agency has issued any warning letters where training and education issues were the only problems with Part 117 compliance.  Of course, better training and education could prevent some of the more serious CGMP violations in the areas of plant sanitation and personnel hygiene, as are frequently cited in FDA’s warning letters,