Wyeth Pharmaceutical Division of Wyeth Holdings LLC – FDA 483, Oct 8, 2008

During an inspection conducted from May 27 to October 8, 2008, the FDA observed six violations. The firm's laboratory test methodologies for minerals were deemed inappropriate, showing negative trends, OOS CV standards, and invalid results requiring re-tests, yet the method remained in use. The seal integrity test for plastic bottles lacked scientific validity, relying on finger pressure and visual inspection without established specifications for pressure, dwell time, or measurable tools.

Specifications for dietary ingredient ginseng, under Monograph Icode_l, required pesticide (tricyclazole) testing verification on supplier COAs, but the firm's COAs did not include these results and were not updated with the correct lab information. In the packaging area, cap adjustment documentation for proper alignment was missing from Master Packaging Records, and there was no evidence that bulk materials, including tablets in metal detector challenge bottles, were removed and destroyed during product changeovers.

Furthermore, only four of five corrective actions were implemented as part of the Master Corrective Action Plan for mineral testing under LIR commitment. Finally, the men's restroom handwashing facility on one side of the floor dispensed only cold water, failing to provide water at a suitable temperature.