API MANUFACTURING FACILITY IS CITED FOR SEVERAL REPEAT WATER RELATED OBSERVATIONS During the time frame of March 13 to March 23, 2012 the FDA inspected Abbey Color, an active pharmaceutical ingredient (API) manufacturing facility in Philadelphia, PA. Following a detailed review of the firm’s response, dated April 12, 2012, the FDA concluded that … [Read more...]
Indian Mexican API Facilities Cited by FDA in Warning Letter
Dr. Reddy's Laboratories Found in Non-Compliance and In Receipt of an Import Ban Comment Dr Reddy's Mexico facilities were inspected between November 8-11, 2010. During the audit the FDA identified significant deviations from CGMP for the manufacture of APIs. These deviations caused the APIs to be adulterated. A response dated December 1, 2010, received by the Agency, … [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...]
