Pfizer Subsidiary Cited for Employee Training, Sample Inspections

The FDA hit Pfizer subsidiary Pharmacia & Upjohn with a Form 483 for inadequate employee training, poor equipment maintenance practices and inadequate sample inspection procedures.

After a November inspection of the drugmaker’s Kalamazoo, Michigan facility, FDA investigators noted that the firm’s training program for retained sample inspections did not require demonstration of the ability to identify all potential defects.

Specifically, the FDA cited the firm’s training program for annual inspection of retail samples of a finished drug product.