California OTC Drugmaker Warned for Testing, Quality Unit Violations

November 26, 2019

The FDA hit a Rancho Cucamonga drug manufacturer with a warning letter for serious GMP violations at its facility including inadequate testing.

The agency, which inspected the OTC drugmaker Swabplus from March 19 to April 11, took the firm to task for not testing the quality of incoming components, including the active ingredient benzalkonium chloride. The firm relied instead on certificates of analyses from unqualified vendors.

You can only rely on a COA for other component attributes by validating the supplier’s test results at appropriate intervals,” the FDA said, noting that a previous inspection of the facility had revealed a failure to periodically verify the reliability of supplier certificates.

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