USE “KEY WORDS’ THAT PROVIDE FOCUSED SEARCHES Barry A Friedman, PhD has been publishing a variety of Regulatory Actions including information regarding Warning Letters, Recalls, and other regulatory activities for over three years. These 140+ Regulatory Actions often include FDA related activities that are not readily found within the FDA … [Read more...]
CANTON LABORATORIES PVT. LTD, INDIA RECEIVES WARNING LETTER (2/27/14)
FIRM FALSIFIES MICROBIAL DATA Canton Laboratories, India was found to have reported analytical results without having performed the testing. C of A’s stated that the data conformed to specifications; however, multiple personnel confirmed that the testing was not performed. Similar data was observed in July 2008 with other testing. Please read below to learn more about … [Read more...]
BAXTER INITIATES U.S. VOLUNTARY RECALL OF ONE LOT OF PERITONEAL DIALYSIS SOLUTION (3/05/14)
CONTAINER-CLOSURE NON-INTEGRITY APPEARS TO PERMIT MOLD GROWTH COMMENT Baxter International Inc initiated a recall for a single lot of DIANEAL PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose. While the recall is due to non-integrity of the container-closure, it appears that complaints of particulate matter, identified as mold, were growing within the 6000 mL bags from … [Read more...]
ISSUE WITH STERILITY CONTROLS WITHIN MANUFACTURING LEADS TO RECALL (1/16/14)
ISSUE OCCURS WITHIN VIETNAM PRODUCTION FACILITY The Mentholatum Co. recently issued a Recall for several different eye drops that were manufactured in Vietnam. Similar eye drops manufactured in Japan were not included within this Recall. The Recall was initiated due to a manufacturing review at the Vietnam production facility and involved sterility … [Read more...]
FDA ANNOUNCES VOLUNTARY NATIONWIDE RECALL OF ALL NON-EXPIRED STERILE DRUGS FROM ABRAMS ROYAL COMPOUNDING PHARMACY (12/21/13)
MICROBIAL ADVERSE EVENT CAUSES RECALL The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, Texas. The recalled products include injectable … [Read more...]
