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...]
TRIAD GROUP RAIDED BY U.S. MARSHAL SERVICE (APRIL 4, 2011)
TRIAD GROUP RAIDED BY U.S. MARSHAL SERVICE (APRIL 4, 2011) See also new FDA-483 from March 28, 2011 (Link attached below) HARTLAND, Wis.— A medical products maker in Hartland ceased production Monday after the U.S. Marshals Service arrived to quarantine or seize materials. The Milwaukee Journal Sentinel reports H&P Industries, which makes alcohol wipes and other … [Read more...]
More on….McNeil-PPC and Two of Its Officers (J&J)
More on....McNeil-PPC and Two of Its Officers (J&J) United States v. Park, 421 U.S. 658 (1975) More on....McNeil-PPC and two of its officers for failing to comply with current good manufacturing practice requirements as required by federal law. The U.S. Supreme Court reversed a decision by the Court of Appeals in which the president of Acme Markets, Inc. was charged with … [Read more...]
