FDA cites Actavis Totowa for poor reporting, stability testing.Following an inspection Sept. 5-28, 2007, FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. Investigator Kristy Zielny issued a three-item 483 to Actavis Totowa, a maker of generic drugs in Little Falls Little Falls is the name of some places in the United States of America:
In April 2008, the firm initiated a Class I nationwide recall of Digitek (digoxin digoxin: see digitalis. tablets, USP USP - unique sales point ) for oral use. The products are distributed by Mylan Pharmaceuticals under a "Bertek" label and by UDL UDL Universal Design for Learning UDL Universitat de Lleida (Spain) UDL Universal Data Link UDL Urban Debate League UDL Uniformly Distributed Load (mechanics, building trade) UDL User Defined Logic Laboratories under a "UDL" label, according to a company news release. The voluntary all-lot recall was due to the possibility that tablets with double the appropriate thickness may have been commercially released, the firm noted. Actavis said the tablets may contain twice the approved level of active ingredient than is appropriate. According to the 483, digoxin did not appear to figure in the inspection. Instead, FDA said the company had not submitted an NDA-Field Alert Report within three working days of receipt of out-of-specification results for a lot of Carisoprodol, Aspirin and Codeine Phosphate codeine phosphate Warning - High-alert drug! Pharmacologic class: Opioid agonist Therapeutic class: Opioid analgesic, antitussive Controlled substance schedule II Tablets, 200 mg/325 mg/ 16 mg at the 12-month stability test interval. The original OOS OOS occupational overuse syndrome: pain caused by repeated awkward movements while at work result was received on Aug. 21, 2007, and results were confirmed as OOS on Aug. 28, but the Field Alert was not submitted until Sept. 9, 2007. Actavis Totowa also failed to follow written production and process control procedures in the execution of production and process control functions, the inspector observed. The Standard Operating Procedures standard operating procedure Medtalk A technique, method or therapy performed 'by the book,' using a standard protocol meeting internally or externally defined criteria; a formal, written procedure that describes how specific lab operations are to be performed. "Investigation of Deviations" and "Investigation of Out of Specification Results" require that investigations be initiated when a deviation or out-of-specification result is detected and be closed within 30 days. However, the report stated, the company did not follow these SOPs in all such situations. No investigation was initiated on Sept. 5, 2007, although a blend was placed on hold for unidentified particles. An investigation for low yield in a lot of Carisoprodol, Aspirin and Codeine Phosphate Tablets USP200/325/16mg was not begun, the report stated. The batch record was signed off as reviewed and approved by production management prior to the investigation. Investigation of Deviation Reports were issued on Jan. 19 and Jan. 29, 2007, but were not closed until May 25, 2007. Actavis Totowa, Little Falls, NJ, 9/5-28/07, Doc. 110091, $3 plus retrieval * The Checklist--Actavis Totowa * Delayed Field Alert * Deviation from SOPs |
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