Three Drug Manufacturers Earn Warning Letters for GMP Violations

January 23, 2017

The FDA handed warning letters to three drug manufacturers, citing them for GMP violations that range from data integrity deficiencies to sterility control failures.

The warning letter to Sato Kogyo stems from a June 2016 inspection and faults the company for its handling of electronic data records. FDA investigators found that the company failed to appropriately maintain uniformity and identity testing information. The company also neglected to implement an audit trail.

During the inspection, an employee revealed that the company conducts repeat testing without scientific justification or documentation and that the staff is not required to maintain the records from the original results when there are suitability failures or suspected errors.

Horizon Pharmaceuticals received a warning letter after an October 2015 inspection revealed that the company failed to establish appropriate laboratory controls. An inspection at Suzhou Pharmaceutical Technology in June 2016 showed that the company omitted the name and address of original API manufacturers on certificates of analysis.

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