FDA Threatens Import Refusal for Three Food Facilities, May Assess Reinspection Fees
The Food and Drug Administration threatened three food manufacturers with import refusal, and said it would collect reinspection fees, for violations of current good manufacturing practice (CGMP) regulations. Chan Yee Jai of Hong Kong (here) and Productos Alimenticios Centroamericanos of Guatemala (here) were both cited for violations of food CGMP regulations at 21 CFR 110, while COVI S.A.S. of France (here) was cited for violations of CGMP for low-acid canned food regulations at 21 CFR 113. A lack of response, or an inadequate response, will result in detention without physical examination at the border for products form each facility, FDA said.
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Because each facility’s violations were found to be materially related to food safety, FDA will conduct a reinspection of each facility to ensure compliance, and may charge fees to each facility to cover associated costs. FDA urged each company to notify their U.S. agents of the fee liability with a copy of the letter.