FDA EIR - CMP Pharma Inc - May 11, 2016

An FDA inspection of CMP Pharma Inc. in Farmville, NC, was conducted from May 10-11, 2016, as a routine drug manufacturing process inspection under Compliance Program Guidance Manual 7356.002. The inspection identified several significant issues related to the company's adherence to good manufacturing practices, specifically concerning its laboratory and quality control systems.

Key violations included deficiencies in laboratory controls, such as the absence of scientifically supported expiration dates for HPLC solutions and general test solutions, and a lack of data to justify a blanket two-year retest date for raw materials (21 CFR 211.160(b)). The Quality Assurance unit failed to ensure timely annual reviews and updates of critical Standard Operating Procedures (SOPs), with several identified in prior years remaining unaddressed (21 CFR 211.22(d)). Furthermore, investigations into discrepancies and out-of-specification results lacked complete documentation, including follow-up actions and specific batch reviews (21 CFR 211.192). Finally, the firm utilized critical production equipment with only handwritten instructions instead of formally reviewed and approved written procedures (21 CFR 211.100(a)).

CMP Pharma management acknowledged these findings and committed to providing written responses addressing each observation. The FDA also noted the importance of completing Annual Product Reviews in a timely manner. The inspection concluded with an emphasis on the company's ongoing responsibility to ensure full compliance with established regulations.