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Article: Process validation and testing assurance needed at Anacapa Technologies.(Human Drugs)
- Article from:
- Validation Times
- Article date:
- January 1, 2009
- Author:
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Anacapa Technologies, a manufacturer of antimicrobial skin and wound care products, received a three-item 483 following a July 16-23, 2007, inspection.
FDA inspector Virgilio Facio found that the San Dimas, CA, 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.
The company also failed to ...