Chinese OTC Maker Placed on Import Alert for Testing Violations

August 23, 2018

The FDA issued a warning letter to Hangzhou Karic Commodities and placed it on an import alert after an inspection of its Hangzhou, Zhejiang facility revealed numerous violations, including a failure to test batches for conformity prior to release.

The March inspection of the firm’s contract manufacturing plant found CGMP violations related to product testing. For example, the company failed to check that each batch of drug product conformed to specifications for active ingredient identity and strength.

The facility also failed to test the quality attributes of inactive ingredients and incoming raw materials, instead using certificates of analysis from suppliers that were not evaluated for reliability.

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