FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Chinese OTC Drugmaker Warned for Process Control Failures

Sept. 14, 2018
A A

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.

View today's stories