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January 22, 2013
OREM, Utah FDA has warned Food for Health International, LLC (FFH) that it is violating Current Good Manufacturing Practices (CGMPs).
In a letter dated Oct. 5, 2012, the government agency said its investigators detected the infractions during an inspection of the company's manufacturing facility several months earlier.
Utah-based FFH was given 15 days to respond to the FDA's letter.
Marc Ullman, a partner with the law firm Ullman, Shapiro & Ullman LLP, raised the possibility that FDA would file an injunction against the company if it doesn't adequately respond to the agency and deliver on its promises.
Among some of the CGMP violations FDA cited:
· Promoting the Activz Control product for conditions that cause it to be a drug under federal law;
· Failure to prepare a written master manufacturing record (MMR) for each unique formulation of dietary supplement that the company manufactures, and each batch size;
· Failure to establish written procedures for packaging and labeling operations;
· Failure to establish written procedures for the responsibilities of the quality control operations;
· Failure to establish written procedures for manufacturing operations
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