FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Chinese OTC Drugmaker Warned for Process Control Failures

Sept. 14, 2018

The FDA issued a warning letter to Longood Medicine, a Beijing-based drugmaker, for process control violations and for using an unapproved drug in the formulation of one of its products.

During a Sept. 25-29 inspection, the agency found that the firm’s sterile swab product, the Chlora-Cleanze Proprep applicator, uses a formulation that isn’t covered under the OTC Drug Review for use as a topical antimicrobial in humans.

The FDA investigators found that the firm’s process control monitoring was inadequate for ensuring stable manufacturing procedures and consistent drug quality for the sterile swabs.

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