FDA EIR - CMP Pharma Inc - June 28, 2018

A Food and Drug Administration (FDA) inspection of CMP Pharma Inc. in Farmville, NC, was conducted from June 26-28, 2018. The inspection, focusing on human drug manufacturing, identified several deviations from regulatory requirements, leading to the issuance of a two-item Form FDA-483, Inspectional Observations. The overall classification of the inspection was Voluntary Action Indicated (VAI), indicating that while issues were noted, regulatory action was not immediately warranted.Key violations centered on the firm's quality control unit and investigation processes. The company failed to complete its required Annual Product Reviews for 2017, a critical step for assessing manufacturing consistency and identifying trends. Furthermore, a Quality/Supplier Agreement was missing for a contract laboratory conducting microbial testing, a clear deviation from internal vendor qualification procedures. Regarding investigations, the Corrective Action and Preventive Action (CAPA) procedure lacked provisions for effectiveness checks, potentially allowing problems to recur without verification. Additionally, the deviation procedure did not provide adequate guidance for conducting root-cause analyses or historical reviews of similar incidents, hindering comprehensive problem-solving.These observations were made within the regulatory framework for drug manufacturing inspections, specifically referencing sections of 21 CFR 211 concerning quality control unit responsibilities and investigation records. As a result, CMP Pharma Inc. is required to formally respond to the FDA within 15 days, detailing how they plan to address each observation. The inspection also highlighted additional areas for improvement, including adhering to procedures for destroying expired retained samples and ensuring cleaning Standard Operating Procedures accurately reflect documented practices.