The batch production record for lot [redacted] of [redacted] is deficient because it does not represent the formula and ingredients that the product purports on its label. Specifically, the batch record does not list all inactive ingredients included on the product label. The batch record also lacked the actual amounts of each active and inactive ingredient used during manufacturing, a calculation of theoretical or actual yields, documentation of the equipment used, and critical manufacturing parameters such as [redacted] speeds and [redacted] times.
Wednesday, June 19, 2019
Warning Letter of the Week: casual batch record edition
Via an epistle from the Center for Drug Evaluation and Research to the Plant Manager of Vida International, Inc. in Taipei City, Taiwan:
Eh, just throw the stuff in there, let it stir around for a while, take it out.