A Pharmacia & Upjohn plant was slammed with its second FDA Form 483 in five years for failure to investigate discrepancies and out-of-specifications results, inadequate annual product reviews, failure to follow written procedures and inadequate documentation for cleaning procedures.
A team of four investigators descended upon the facility on June 23 to July 9, including CDER Office of Manufacturing Quality Director Thomas Cosgrove, who participated as an observer.
The FDA team noted that nonconfirmed OOS investigations weren’t documented to prove that an adequate investigation was performed prior to batch release, and some laboratory investigation reports and lot results records were missing key information on the manufacturing process.
Annual product reviews also were lacking a review of all appropriate data to evaluate quality characteristics, and investigators noted numerous examples of manufacturing equipment missing cleaning logs.
The plant also failed to follow written procedures for identifying, handling and storing containers, and inspectors observed containers that were torn, leaking and associated with rodent infestation were not placed in an area identified as rejected.
Moreover, procedures to prevent microbiological contamination of sterile products weren’t written and followed.
The Kalamazoo, Mich., plant received a 10-item Form 483 following a September 2010 inspection for many of the same issues.
Pfizer spokeswoman Kim Bencker says the recent inspection was a routine GMP inspection, and the company is working closely with the FDA to address the concerns raised.
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