FDA hands another Chinese drug manufacturer a warning letter

The FDA has handed down another warning letter to a Chinese drug manufacturer. This time the warning was issued to Yangzhou Hengyuan Daily Chemical Plastic located in the Hanji Industrial Park in Yangzhou.

During a review of the facility last January, FDA inspectors found a batch of drugs produced at the plant didn’t contain the active ingredient required for the product, which was then denied entry into the U.S. and Yangzhou Hengyuan’s client was notified.

An investigation of the complaint filed by that client showed the Chinese plant added the wrong ingredient to the batch, the FDA said. 

Whitepaper

Simplify and Accelerate Drug R&D With the MarkLogic Data Hub Service for Pharma R&D

Researchers are often unable to access the information they need. And, even when data does get consolidated, researchers find it difficult to sift through it all and make sense of it in order to confidently draw the right conclusions and share the right results. Discover how to quickly and easily find, synthesize, and share information—accelerating and improving R&D.

At the time of the inspection by the regulatory agency, the firm admitted it didn’t test all batches of finished drug product before they were released.

As a result of the incident, the agency slapped an import ban on Yangzhou Hengyuan in August as well as recommended the company hire a consultant to help it meet CGMP standards. 

The company has said it plans to conform to testing drug product batches bound for the U.S.

Yangzhou Hengyuan is just the latest Chinese drug manufacturer to get hit with a warning letter from the FDA this year. China accounts for half global API market and saw its exports of pharma products to the U.S. market increase 4% last year despite ongoing manufacturing problems.

- here’s the FDA warning letter

Related Articles:
China drug exports to U.S. rise but companies struggle with quality 
FDA warnings slam Chinese drugmakers, including ViiV partner 
FDA warns China's Concept Products: test your products 
Chinese API maker spanked in warning letter

Read more on

Suggested Articles

Higher operating costs were behind a 17% slide in pretax profits last year at Allergan’s Mayo, Ireland, facility that produces Botox.

After a global scare over Zantac contamination, generic metformin could be next in line as regulators test for possible carcinogen contamination.

PCI Pharma Services debuts expansion of its plant in Rockford, Illinois.