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...]
FDA 483 TRIAD GROUP OBSERVATIONS (H & P Industries) 11/29/10 -01/07/11
FDA 483 TRIAD GROUP OBSERVATIONS (H & P Industries) 11/29/10 -01/07/11 Comment Enclosed are three of the forty six Observations along with commentary from the 30 page Triad Group FDA 483. These three Observations focus upon the training and education within the Triad Group as noted by the FDA during their investigation. It should be observed … [Read more...]
TRIAD GROUP — VOLUNTARY PRODUCT RECALL AND FDA 483
TRIAD GROUP – VOLUNTARY PRODUCT RECALL JANUARY 5, 2011 FOR IMMEDIATE RELEASE - January 5, 2011 - Hartland, Wisconsin, Triad Group, a manufacturer of over-the-counter products has initiated a voluntary product recall involving ALL LOTS of ALCOHOL PREP PADS, ALCOHOL SWABS, and ALCOHOL SWABSTICKS manufactured by Triad Group but which are private labeled for many accounts to the … [Read more...]
