FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

FDA Cites Indian Manufacturer for Training, Record Deficiencies

Sept. 7, 2018

The FDA hit Indian injectable drugmaker Auronext Pharma over violations found during a February inspection of the company’s Bhiwadi, Rajasthan facility.

The agency called out the firm for inadequate employee training for a 100 percent visual inspection of its sterile drugs. The inspection kit used for training and testing didn’t provide personnel with a full range of visual particulate contamination they could encounter in the batches they would be inspecting.

The investigators also found problems with batch records, with one record including a vial sealing machine operation speed range that was not properly validated.

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