FDA WARNING_LETTER - Andapharm, LLC - July 18, 2018

The FDA inspected ANDAPharm, LLC's drug manufacturing facility from July 10 to 18, 2018, identifying significant violations of current good manufacturing practice (CGMP) regulations (21 CFR parts 210 and 211), rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B). The firm's August 3, 2018, response was deemed inadequate. Key violations included failure to establish and follow adequate written procedures for equipment cleaning and maintenance (21 CFR 211.67(b)), which was a repeat violation from 2012 and 2016 inspections. The firm also failed to establish and follow an adequate stability testing program (21 CFR 211.166(a)), another repeat violation. Additionally, ANDAPharm failed to maintain separate or defined areas to prevent contamination or mix-ups (21 CFR 211.42(c)), and did not follow written procedures for production and process control, including proper documentation at the time of performance (21 CFR 211.100(b)). The FDA noted the firm's quality systems are inadequate and, due to repeat violations, strongly recommended engaging a CGMP consultant. As a contract manufacturer, ANDAPharm is responsible for the quality of drugs produced. The firm must promptly correct these violations within 15 working days to avoid potential legal action, including seizure, injunction, and withholding of drug application approvals or export certificates.