FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

FDA Slaps California OTC Manufacturer for Cleaning, Validating

Dec. 3, 2018
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The FDA hit Torrance, California, OTC drugmaker Medical Chemical for a variety of violations seen at its facility, including inadequate cleaning and validating of equipment.

During its Aug. 6-18 inspection, the agency officials noticed that the facility lacked written procedures for cleaning manufacturing equipment, a repeat observation from 2015.

The facility did not conduct validation studies to check the effectiveness of cleaning agents, cleaning times or maximum clean hold times between completing cleaning and the initiation of the manufacturing operation.

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