CMP Pharma Inc – FDA 483, May 11, 2016
An FDA inspection of CMP Pharma Inc, a drug manufacturer in Farmville, NC, revealed four observations concerning deficiencies in their quality systems. These included inadequate laboratory controls for expiration and retest dating, failure to consistently follow quality control unit procedures for SOP reviews, and incomplete documentation for investigations into discrepancies. Additionally, the firm lacked approved written procedures for the operation of a weight checker used for unit dose products.
ID · ab36b906-a96c-4256-ac74-f28a2964e6d5
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