FDA 483 - CMP Pharma Inc - June 26, 2018
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An FDA inspection of CMP Pharma Inc, a manufacturer in Farmville, NC, revealed significant deficiencies in their quality control unit and investigation procedures. The firm failed to complete required annual product reviews and lacked proper Quality/Supplier Agreements for contract laboratories. Additionally, their written investigation records were inadequate, with CAPA procedures missing effectiveness checks and deviation procedures lacking instructions for root cause analysis and historical reviews.
ID · 2927d0d9-9a84-42dc-9147-5158673f4bdf