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Wyeth 483 Relates to Investigation Failures

December 3, 2010
A Wyeth facility in Virginia was handed a Form 483 noting several investigation deviations.

For example, the Henrico, Va., facility failed to extend one of its investigations to other batches, the form says. Another investigation did not ensure that all OTC products were consistent with the requirements of the OTC monograph.

The company also did not conduct training after an investigation found that although packaging technicians removed unapproved foil from the packaging line, some of the suspect material was left in the holding area.
Drug GMP Report