HOSPIRA'S IRUNGATTUKOTTAI FACILITY RECEIVES WARNING LETTER (052813) Recently Ranbaxy settled a $500 million lawsuit with the Dept. of Justice for selling improperly manufactured and tested drugs (see previous Blogs). More recently, Maharashtra-based Wockhardt received an Import ban (see previous Blogs to learn of what other Indian based … [Read more...]
HAMELN PHARMACEUTICALS, HAMELN, GERMANY RECEIVES WARNING LETTER (12/17/12)
IN-HOUSE STERILITY TESTING METHOD NOT EQUIVALENT TO USP<71> During the time frame of June 4 - 14, 2012, the Hameln facility was audited by the FDA. Following the audit, the firm responded on July 4, August 2 and 31, and September 8, 2012. Even with all of these responses, the FDA found that the firm lacked sufficient corrective actions. For … [Read more...]
TOP POSTINGS FROM THE BLOG OF BARRY A. FRIEDMAN, Ph.D., LLC — 2012
Often the question is asked "what were your top postings during the previous year. This is an intriguing question since I don't know myself until I review the postings at the end of each year. With an accumulation of over 70,000 views, it is of interest to determine what you, the viewers, deemed to be the most important. I have now sorted through the … [Read more...]
MOST FREQUENTLY VIEWED POSTINGS — YEAR TO DATE FROM THE BLOG OF BARRY A FRIEDMAN, PhD
Periodically individuals have contacted me to learn of the "most frequently viewed postings" on my Blog. On occasion, I ask myself the same question. As a result I am posting the "top six" requested sites for your review. You may find one or more of these postings of interest to you. Each of these remains available and is easy … [Read more...]
REGULATORY COMPLIANCE/EXPERT MICROBIOLOGICAL WITNESS CONSULTATION
Regulatory Compliance -- Form FDA 483/Warning Letters With the advent of only 15 calendar days to respond to regulators following a Form FDA 483 or Warning Letter, it is incumbent upon the recipients of these to use the time most productively to minimize any further regulatory actions. Understanding the Observation becomes the initial step. Unless the individuals are … [Read more...]
