FIRM FAILS TO SUFFICIENTLY INVESTIGATE PHARMACEUTICAL WASTE CONTAMINATION EVENT During an FDAÂ investigation of SKBÂ in Cork, Ireland, the FDA encountered an unusual situation where the pharmaceutical waste tank was found to have contaminated various other tankage used to manufacture APIs. Part of the rationale provided by SKB was that no reason existed … [Read more...]
FDA’S CDER LISTING OF TOP EIGHTEEN OBSERVATIONS FOR 2013
TOP FOUR OBSERVATIONS INCREASE SIGNIFICANTLY OVER 2012 Each fiscal year the FDA issues the various FDA 483 Observations from the various Centers to include CBER, CDER, CDRH, etc. This Blog focuses only upon those issued by Center for Drug Evaluation and Research (CDER) and will concentrate upon those found within 21 CFR Part 211. Interestingly, while … [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...]
