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...]
TRIAD GROUP HARTLAND, WI FORM FDA-483 INSPECTION DATES 11/29/2010 – 1/7/11
Triad Group Hartland, WI Form FDA-483 Inspection Dates 11/29/2010 - 1/7/2011 Comment Enclosed are comments from a total of seven observations representing various Systems to include Laboratory Control, Production, and Material obtained as a subset from the forty six observations within Triad Group's recent FDA 483 which resulted in a recall of their alcohol prep pads, … [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...]
