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Article: OTC manufacturer changes product specs following validation.(Human drugs)
- Article from:
- Validation Times
- Article date:
- May 1, 2004
- Author:
CopyrightCOPYRIGHT 2004 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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Validation deficiencies, out-of-specification (OOS) test results and failure to investigate were among quality system deficiencies that netted OTC pharmaceutical manufacturer Pharmaceutical Formulations Inc. (PFI) a nine-item 483 following a recent inspection.
FDA investigators Kelli Dobilas and Ernest Bizjak of the North Brunswick, NJ, Resident Post, New Jersey District, conducted the drug process inspection that covered the firm's Quality, Laboratory and Production systems.
A previous 2001 inspection resulted in a 483 for process validation deficiencies and failure of the Quality Unit to maintain responsibility and authority to review and conduct ...