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...]
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...]
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...]
Johnson & Johnson McNeil-PPC Consent Decree and Permanent Injunction
Johnson & Johnson McNeil-PPC Consent Decree and Permanent Injunction Comment The recent Consent Decree and Permanent Injunction against McNeil-PPC and two of its Vice Presidents recalled an article from March 2010 re: "FDA Recommends Increased Criminal Prosecutions of Responsible Corporate Officials...". The initial paragraph is enclosed below. … [Read more...]
FDA FILES CONSENT DECREE OF PERMANENT INJUNCTION AGAINST MCNEIL-PPC AND TWO OF ITS OFFICERS
FDA NEWS RELEASE Comment The FDA issued a Consent Decree of Permanent Injunction bypassing a Warning Letter in their persuit of J & J's failure to comply with CGMPs. For Immediate Release: March 10 2011 Media Inquiries: Shelly Burgess, 301-796-4651; shelly.burgess@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA FDA, Justice Department take action against McNeil-PPC … [Read more...]
