|
|
Article: OTC manufacturer cited for OOS results, quality failures.(Human Drugs)
- Article from:
- Inspection Monitor
- Article date:
- April 1, 2004
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)
|
Pharmaceutical Formulations Inc., Edison, NJ, North Brunswick Resident Post, NJ District
OOS results, validation deficiencies 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 New Jersey District's North Brunswick Resident Post conducted the drug process inspection that covered the firm's Quality, Laboratory and Production systems.
A previous audit in April 2001, covered quality and production systems and resulted in a 483 because the Quality ...