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Article: FDA finds control, testing issues at Anacapa Technologies.(HUMAN DRUGS)
- Article from:
- Inspection Monitor
- Article date:
- January 1, 2009
CopyrightCOPYRIGHT 2009 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Anacapa Technologies, San Dimas, CA Los Angeles District
Drug manufacturer Anacapa Technologies received a three-item 483 from FDA investigator Virgilio Facio following an inspection July 16-23, 2007.
The inspector found that the company had not established control procedures that validated the performance of manufacturing processes that could cause variability in the characteristics of in-process material and the drug product. Specifically, the firm failed to conduct process validation studies for the finished OTC topical drug Extra Strength Anasept2 Skin First Aid Antiseptic liquid; one lot of this finished product was distributed in May 2006.
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