FDA Warns South Korean Drugmaker for Multiple cGMP Failures
South Korean OTC drug manufacturer Enprani drew a warning letter from the FDA for cGMP violations observed by FDA investigators at its Incheon facility — including the release of products for sale in the U.S. without checking the identity and strength of their active ingredients.
The facility’s quality unit neglected to review complete batch records before making a release decision. It also pre-printed batch records as “approved” before getting the assay results and failed to perform label reviews and to document them in batch records, the agency said.
Staff admitted that the facility stopped testing for the active ingredient after Sept. 15, 2017 because they had “previously obtained consistent passing results,” the FDA said.