Smoke Study Findings Contribute to Mylan Laboratories Warning Letter (8/06/2015)

The following is the second Blog in an on-going series of Blogs obtained from a Warning Letter about Mylan Laboratories, Bangalore, India as well as other Mylan (Agila Specialties Private Ltd.) facilities in India. This second Blog continues the review of the Mylan facilities which were audited February 6-13, 2015 and are located at Plot No. 284-B (19A) Bommasandra Jigani Link … [Read more...]

A REVIEW OF AN EXTENSIVE ENDOTOXIN WARNING LETTER USING THE NEW FDA “ENDOTOXIN” Q&A AS A BACKDROP

GENERAL The following Blog was initially published on October 1, 2012.  Teva Parenterals Medicines had received a Warning Letter in December 2009 describing extensive issues with Endotoxin. To obtain more information on this subject, please plan to attend a webinar on Wednesday, September 9 sponsored by Tungsten Shield and click here. COMMENT In December 2009 (12/11/09) … [Read more...]

Quality Metrics and Risk Based Inspections

FDA’s Request for Quality Metrics (New Proposed Guidance July 2015) and Its Basis – The FDA’s Safety and Innovation Act (FDASIA) A Live, Interactive Training Webinar; See: http://www.tungstenshield.com/barry-a-friedman-phd/ Date: Tuesday August 18, 2015 Time: 9:30 - 11:30 AM ET (New York Time) Instructor: Barry A.Friedman Ph.D. Quality Metrics and Risk Based … [Read more...]

FDA’s CDER LISTING OF TOP NINETEEN OBSERVATIONS FOR 2014

TOP FOUR OBSERVATIONS REMAIN SIMILAR IN NUMBER TO 2013 Each fiscal year the FDA issues the various FDA 483 Observations from the various Centers to include CBER, CDER, CDRH, etc.  This Blog focuses only upon those issued by the Center for Drug Evaluation and Research (CDER) and will concentrate upon those found within 21 CFR Part 211.  Interestingly, while the order of the … [Read more...]

2015 United States Pharmacopeia (USP) Microbiological General and Information Chapters Training Program

7-Part Live Training Program Starts September 30, 2015 Instructor: Barry A. Friedman Ph.D. Biography>>> Click Here to Learn More and to Register for this Live Training Program The United States Pharmacopeia (USP) contains a number of chapters relating to microbiology within its General and General Information Chapters. These Chapters present information … [Read more...]