OBTAIN THE ANSWERS TO THE QUESTIONS THAT EVERYONE ASKS This Blog site periodically provides 483s and Warning Letters as well as commentary as a service to its clientele. A question frequently asked is “when is a 483 issued as well as what are the implications of a 483”. The FDA has recently issued a “FDA Form 483 Frequently Asked Questions” on their web site that addresses … [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...]
FREQUENTLY ASKED QUESTIONS — USP GENERAL CHAPTER (REVISED)
Microbial Examination of Nonsterile Products: Microbial Enumeration Tests USP <61> Q. Can I use strains other than those that are cited in the USP? A. You should use the strains that are cited in this chapter or equivalent strains from other culture collections. For example, if Pseudomonas aeruginosa ATCC 9027 is indicated, you should use this strain or strains … [Read more...]
