FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Drug Contained Wrong Ingredient, Company Failed to Test Product, FDA Says

Oct. 18, 2016

The Yangzhou Hengyuan Daily Chemical Plastic Co. received a warning letter after the FDA found that one of its drugs was missing the active ingredient and that the company was not testing finished batches of drug products.

The China-based company received the warning letter after a January inspection that summarized significant violations, including a failure to provide adequate written production and control procedures designed to assure that the drug products produced have the correct identity, strength, quality and purity.

The FDA collected samples of the company’s drugs at the port of entry, and a laboratory analysis found that the drugs did not contain the labeled active ingredient.

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