OTC Drugmaker Gets Warning Letter From FDA Record Review

The FDA has exercised its new authority to use remote records reviews in lieu of certain types of GMP inspections, issuing a warning letter to Green Pharmaceutical of South Korea based on a review of records it requested on March 3.

The Aug. 23 warning letter cites the company for failure “to conduct at least one test to verify the identity of each component of a drug product” and failure “to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products.”

The letter also notes that the company was put on an import alert July 17.

Read the warning letter here.

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