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...]
TRIAD GROUP AND H & P INDUSTRIES RECEIVE ANOTHER FDA-483 ON MARCH 28, 2011
FDA-483 ARRIVES ONE WEEK PRIOR TO SEIZURE Comment The FDA released additional information regarding its most recent inspection (March 21 - 28, 2011) in the same press release that described its seizure of over $6 million dollars of various drug products. The five page, ten observation FDA-483 (see previous Blog on same subject) continues to demonstrate a pattern that was … [Read more...]
FDA ORDERS SEIZURE OF TRIAD PRODUCT WORTH $6 MILLION
FDA Orders Seizure Of Antiseptic, Antifungal Products Worth $6 Million The AP (4/6) reported that the Food and Drug Administration "said Wednesday that antiseptic products made by Triad Group and H&P Industries were seized to prevent the distribution of products that might be contaminated and pose a health risk." At the FDA's request, US Marshals seized more than "$6 … [Read more...]
FDA ISSUES — MEDIA GROWTH PROMOTION STUDIES McNEIL-PPC, DELTEX PHARMA, RIBBON PHARMA & CHEMICAL, COLUMBIA PRESBYTERIAN MEDICAL CENTER
FDA ISSUES -- MEDIA GROWTH Â PROMOTION STUDIES McNEIL-PPC, DELTEXÂ PHARMA, RIBBON PHARMAÂ & CHEMICAL, COLUMBIA PRESBYTERIAN MEDICAL CENTER Comment Comments Regarding Proposed Changes to USP General Chapter <823> Radiopharmaceuticals for Positron Emission Tomography-Compounding were recently made to the USP as they move forward in … [Read more...]
