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Pharmaceuticals / Inspections and Audits

FDA Flags Drugmaking Problems at Chinese Company

Nov. 27, 2017

The FDA cited a Chinese medical instrument company for problems in the manufacturing of drugs included in its production.

In a warning letter based on visits from CDER inspectors in March to the Wuxi Medical Instrument Factory in Jiangsu province, the FDA said Wuxi committed violations of good manufacturing practices standards for drug production, including: failure to validate the manufacture of sterile products, to establish laboratory procedures to ensure purity and quality, to adequately clean equipment and utensils and to maintain adequate records of equipment maintenance.

The company showed inspectors records that it said recorded sanitization processes from January to March as they occurred, but the records actually were filled in on the second day of the FDA inspection in March.

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