FDA 483 - Wyeth Pharmaceutical Division of Wyeth Holdings LLC - November 18, 2022

An FDA inspection of Wyeth Pharmaceutical Division of Wyeth Holdings LLC in Sanford, NC, a bulk vaccine manufacturer, identified deficiencies in written calibration procedures for instruments and analytical methods. Specifically, the firm failed to include specific limits for accuracy and precision for critical test sampling and did not properly utilize reference standards or bracket samples in analytical sequences. These issues indicate a lack of adequate control over critical testing processes.