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US FDA has issued warning letters to three European and one Chinese drugmaker

String of warning letters has been issued by US FDA at facilities run by firms in China, the UK, The Netherlands, Switzerland and China due to cGMP violations.

The US Food and Drug Administration inspected the Chinese company’s facility in Yangzhou, Jiangsu in January this year and observed failures to provide adequate written production and control procedures. FDA collected samples of a particular batch at the port of entry and found absence of any of the labeled active ingredient. FDA denied entry of the shipment accordingly and notified the customer which filed a complaint with the company.”The FDA also pulled the firm up on its lack of appropriate laboratory determination of satisfactory conformance. For example: “the company’s investigation indicated the warehouse released the wrong active ingredient for a particular batch. This was the first of multiple errors that led to adding the wrong ingredient to company’s drug product.”According to company’s website , the company makes consumer health products including toothpastes and ‘hotel amenities,’ but the FDA letter indicate the facility also makes finished pharmaceuticals.

On inspection of Delarange Cosmetics Healthcare, Netherlands, FDA found significant violations of current good manufacturing practice which included problems in determining strength of active ingredients in private label products and a failure to establish an appropriate quality control unit. The FDA also found the company had failed to establish written procedures for cleaning and maintenance of equipment.

Laboratoire SintylOver to Switzerland, and a facility run by Laboratoire Sintyl in Geneva inspected in June was also pulled up on quality control problems and failure to test the identity and strength of active ingredients.


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