OTC manufacturer cited for OOS results, quality failures.(Human Drugs)

Inspection Monitor | April 1, 2004 | Copyright

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 ...

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