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...]
PERFORMANCE PRODUCTS INC, ST LOUIS, MO RECEIVES WARNING LETTER (11/20/12)
COMPANY FAILS TO REPLY TO FORM FDA 483 FROM JULY 2012 AUDIT Compliance Products, St. Louis, MO was audited by the Kansas City office of the FDA from July 16-20, 2012. Following the audit, a total of eight Observations were issued. As of the date of the Warning Letter, no response had been received by the FDA. Many of the Observations represented recurring Observations – … [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...]
HEMOFARM A.D., VRSAC, SERBIA, RECEIVES WARNING LETTER (6/20/12) FOR ASEPTIC PROCESSING ISSUES
EXAMINE HOW THE REVISED USP<1116> RELATES TO THESE OBSERVATIONS FIRM IS PLACED UNDER FDA IMPORT ALERT Hemofarm A.D., Vrsac, Serbia recently received a four Observation Warning Letter for unreliable environmental (to include microbiological) monitoring data. Several of the CGMP violations listed in their letter include … [Read more...]
INTERNATIONAL LABORATORIES (CANADA) LTD RECEIVES FDA (CDER) WARNING LETTER (10/23/12)
NO FDA EXPORT BAN (REFUSAL OF ADMISSION) IS ISSUED The FDA conducted an inspection of International Laboratories from February 13 – 16, 2012 at their facilities in Calgary, Alberta. While the Company responded within 15 business days, the responses to the audit were unsatisfactory and a Warning Letter containing five Observations was … [Read more...]
