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Indian Drugmaker Cited for Numerous Violations

March 27, 2018

An FDA inspection of drugmaker Goran Pharma in November netted the company a Form 483 with 17 observations ranging from inadequate employee training to laboratory deficiencies and contamination risks.

The facility inspection in Sihor, Gujarat found many deficiencies in the microbiology laboratory. It did not have a separate unit for handling live organisms, and it did not document load, pressure or time for each sterilization cycle or use a biological indicator to verify sterilization.

The investigator also observed that employees did not wear socks when working in manufacturing, processing and packaging areas and some wore short sleeve, open collar shirts while transferring components, in-process materials and finished product.

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