FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

California OTC Firm Written Up for Missing Validations

Oct. 7, 2019
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The FDA cited an OTC drugmaker in California for violations at its facility involving its manufacturing equipment and quality system.

An agency inspection of the Lifetech Resources facility in Moorpark revealed inadequate cleaning validations and annual OTC drug product reviews.

Specifically, the facility failed to conduct cleaning validations for equipment used in OTC drug product manufacturing and filling.

In addition, the firm did not complete 2017 and 2018 annual product reviews for the OTC drugs as required by its standard operating procedure.

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