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Barry A. Friedman, PhD LLC

FDA Regulatory Compliance for the Pharmaceutical, Biotechnology and Medical Device Arenas

PERFORMANCE PRODUCTS INC, ST LOUIS, MO RECEIVES WARNING LETTER (11/20/12)

January 13, 2013 By Barry Friedman Leave a Comment

COMPANY FAILS TO REPLY TO FORM FDA 483 FROM JULY 2012 AUDIT Compliance Products, St. Louis, MO was audited by the Kansas City office of the FDA from July 16-20, 2012.  Following the audit, a total of eight Observations were issued.  As of the date of the Warning Letter, no response had been received by the FDA.  Many of the Observations represented recurring Observations – … [Read more...]

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