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...]
AMERIDOSE, LLC RECEIVES 15 OBSERVATIONS AS PART OF FORM FDA 483 (11/09/12)
SISTER COMPANY OF NECC RECEIVES TWENTY PAGE 483 CONTAINING SEVERAL REPEAT OBSERVATIONS COMMENT The FDA conducted an inspection of Ameridose, LLC, Westborough, MA from October 10 through November 9, 2012. The investigation, involved fourteen Investigators and three microbiologists including one microbiologist from CDER. A total of fifteen Observations including several … [Read more...]
NEW ENGLAND COMPOUNDING CENTER RECEIVES FDA 483 (10/26/12)
FDA INVESTIGATORS CONFIRM CONTAMINATION IN 50 OF 50 VIALS TESTED COMMENT The FDA issued its initial Form FDA 483 regarding the New England Compounding Center located in Framingham, MA. The eight page, five item 483 describes the initial findings of their audit. The Company now has 15 business days to submit its response to the FDA. Of … [Read more...]
FDA’S CDER SUMMARIZES TOP TEN 483 OBSERVATIONS AT PDA/FDA MEETING IN BALTIMORE (9/12)
COMMENT Each year CDER summarizes the number of significant Observations obtained from Form FDA 483s. At this year's PDA/FDA meetings which were held in Baltimore, MD, the FDA presented the totals calendar year to date. The Observations within the top ten usually do not change --- although their frequency may vary. Where a specific section is indicated, the Title indicates … [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...]
