FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Korean Drugmaker Cited for Quality, Testing Failures

Oct. 23, 2018

The FDA flagged South Korean drug manufacturer EEJE for quality and testing deficiencies observed during a July 30 to Aug. 2 inspection of its facility in Gyeongsangnam-do province.

The firm lacked validation documentation to show that its manufacturing and packaging processes were acceptable for a topical drug shipped to the U.S. market between December 2017 and the start of the inspection.

The inspection revealed that drug products intended for distribution weren’t adequately tested to show that their active ingredients’ identity and strength met final specifications. The firm also failed to complete finished product testing to ensure the products met all label claims. For example, it had no test data to verify a certain active ingredient was present as indicated on a finished drug label.

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