FDA Warning Letter


In the FDA warning Letters Posted January 18, 2017 the following topics were identified:

Data Integrity was identified in the FDA warning letter issued to Sato Yakuhin Kogyo Co., Ltd.  The inspection of the audit trails for the HPLC analysis identified multiple runs performed on the same sample however the first set of chromatograms were not retained or available.  Additionally, the firm identified that limited (over a 2-year period only 2-minor deviations) investigations were conducted for unexplained discrepancy or failure of a batch.

Lack of a quality unit was identified n the FDA warning letter issued to Suzhou Pharmaceutical Technology Co., Ltd.  The firm had no document defining the roles and responsibilities of the Quality Unit, and no written procedures.  Salespersons signed the CoA as the Quality Director and Tested By without performing any tests.  The firm took CoA from their suppliers and cut and pasted the testing information onto a form under Suzhou’s letterhead.

Lastly, in the FDA warning letter, Horizon Pharmaceuticals, Inc was cited for lack of controls to minimize microbiological contamination of the firm’s products.  Lack of investigation when out of specification results were obtained and, inadequate visual inspection methods.