FDA 483 - CMP Pharma Inc - June 26, 2018

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.