FDA Hits Pfizer Subsidiary With Second Form 483 in Five Years

A Pharmacia & Upjohn plant was slammed with its second FDA Form 483 in five years for GMP deficiencies ranging from quality systems, facilities and equipment to materials, production and laboratory systems.

Major lapses uncovered during the June 23 to July 9 inspection included failure to investigate discrepancies and out-of-specifications results, inadequate annual product reviews, failure to follow written procedures for identifying, handling and storing containers, and inadequate documentation for cleaning procedures.

The Kalamazoo, Mich., plant received a 10-item Form 483 following a September 2010 inspection for many of the same issues.

Although drugmakers have received repeat 483 observations that have not resulted in further action such as warning letters, the agency will likely take a much harder stance toward companies with repeat observations under its new team-based  inspectorate program.

A team of four investigators descended upon the facility, including CDER Office of Manufacturing Quality Director Thomas Cosgrove, who participated as an observer.

The FDA team noted, for instance, 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 such as content uniformity data, and investigators noted numerous examples of manufacturing equipment that was not designed for its intended use and missing cleaning logs for major equipment.

The plant also failed to follow written procedures for identifying, handling and storing containers. According to the 483, 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.

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.

View the Form 483 at www.fdanews.com/09-28-15-483.pdf. — Tamra Sami