FDA 483 - CMP Pharma Inc - September 01, 2023

CMP Pharma Inc, a drug manufacturer in Farmville, NC, was inspected from August 21 to September 1, 2023. The inspection revealed significant deficiencies in the firm's quality system, specifically concerning the investigation of unexplained discrepancies and batch failures. The firm's procedures for conducting root cause investigations and ensuring the effectiveness of corrective and preventive actions were found to be inadequate.