FDA WARNING_LETTER - PrimaPharm Inc. - May 14, 2008

An FDA inspection of PrimaPharm Inc.'s drug manufacturing facility in San Diego, California, from May 1-14, 2008, revealed significant violations of current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 211), causing their drug products to be adulterated under 21 U.S.C. § 351(a)(2)(B). The inspection also found the firm was manufacturing and marketing unapproved new drugs, violating 21 U.S.C. § 355(a), and that these drugs were misbranded, violating 21 U.S.C. § 352(f)(1).

Key CGMP deviations included: 1. **Inadequate investigations:** Failure to thoroughly investigate unexplained discrepancies, such as media fill failures and out-of-specification results, and to assess the impact on other batches. 2. **Microbiological contamination prevention failures:** Lack of continuous environmental monitoring, inadequate facility design (e.g., direct entry into aseptic areas), and deficient media fill validation procedures. 3. **Environmental monitoring deficiencies:** Failure to sample critical surfaces, perform viable air sampling at the conclusion of product fills, and establish appropriate action limits for personnel monitoring. 4. **Inadequate test method validation:** Lack of defined methods for determining operator qualification for visual inspection and undocumented retraining frequency. 5. **Insufficient cleaning and disinfection