NINGBO SMART PHARMACEUTICAL RELEASE WITH INCOMPLETE C of As Comment The Ningbo Smart Pharmaceutical Co. Ltd, Ningbo China, received an Active Pharmaceutical Ingredient (API) audit between October 25-29, 2010. During this audit, the investigator identified significant deviations from CGMP for the manufacture of APIs. They … [Read more...]
FDA ISSUES WARNING LETTER FOR CLINICAL SUPPLY MANUFACTURING FACILITIES — FEBRUARY 10, 2011
Formatech, Inc Receives Warning Letter at Facility Manufacturing Clinical Trial Materials Comment: Clinical Supply Manufacturing (CMO) facilities are not customarily audited when they produce Phase 1, Phase 2 or Phase 3 Clinical Trial materials. A CMO would not typically receive its initial FDA audit until it requests its Pre-Approval Inspection (PAI) for a new drug. … [Read more...]
