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 PROHIBITS INDIAN FACILITY FROM PRODUCING AND DISTRIBUTING DRUGS FOR U.S. MARKET
ANOTHER RANBAXY FACILITY IS ADDED TO EXISTING CONSENT DECREE The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical  ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products. The Toansa facility is now … [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...]
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...]
NEW ADDITION TO WARNING LETTERS’ “BOILERPLATE” PARAGRAPHS
CDER RESPONDS TO MANAGEMENT OF LACK OF AVAILABILITY OF FINISHED DRUG PRODUCT OR API Recently the FDA has added a new standardized paragraph to each of its Warning Letters for both Finished Drug Products and for Active Pharmaceutical Ingredients. Please review how the FDA desires you to respond. "If, as a result of receiving this Warning Letter or in general, you … [Read more...]
