A RESPONSE TO YOUR QUERIES RE: FREQUENT TOPICS OF INTEREST Periodically, I am asked what are the most frequent topics which interest the reader. Because the reader has so many varied interests, it is difficult to determine this without retrospectively reviewing the data. I have summarized below the “top six” topics that have been viewed since the beginning of 2012. You may … [Read more...]
WINTAC LIMITED INDIA RECEIVES FDA WARNING LETTER (022312)
CITES ASEPTIC MANUFACTURING FACILITY FOR SIGNIFICANT cGMP VIOLATIONS Specific violations observed during the inspection include, but are not limited, to the following: 1. Your firm has not established or followed appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile. Such procedures shall include validation of … [Read more...]
GULF PHARMACEUTICAL INDUSTRIES RECEIVES WARNING LETTER (2/23/12) RELATED TO ASEPTIC PROCESSING
TWO STRIKES AND YOU’RE OUT -- GULF PHARMA REMAINS UNDER FDA IMPORT ALERT. Gulf Pharmaceutical Industries was audited between September 25 and October 3, 2011. During this inspection, the FDA found significant violations related to aseptic processing. Several of these violations were a repetition of violations observed during a … [Read more...]
MERCK KGaA RECEIVES WARNING LETTER (12/15/11)
FDA INCLUDES THREE EUROPEAN FACILITIES TO INCLUDE MERCK SERONO S.A., AUBONNE, SWITZERLAND WITH MEDIA FILL ISSUES The FDA released on Wednesday, February 17, 2012 a Warning Letter that was sent to Merck KGaA on December 15, 2011. Within the Warning Letter the FDA advised Merck KGaA management of deficiencies at three separate facilities, two in Switzerland and one in Rome, … [Read more...]
FDA INCREASES VIGILANCE ON ASEPTIC PROCESSING FACILITIES
 B/POR REVIEWS RISING TIDE OF FDA 483s AND WARNING LETTERS AT FIRMS TO INCLUDE BEN VENUE LABS, HOSPIRA AND FORMATECH COMMENT Policy changes and enforcement strategies implemented by the FDA have led to an increase in the number of inspection of sterile manufacturers -- especially injectables. There is greater … [Read more...]
