Indian Drugmaker Flagged for Numerous Violations

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. It also did not conduct positive and negative growth promotion testing on media after sterilization.

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

The employees also lacked adequate training in current good manufacturing practices. Training is required for all laboratory, production and maintenance staff, but only a small number of supervisors and staff received training. In addition, passing criteria for evaluating the effectiveness of training was not established.

The firm also failed to properly maintain the facility. The investigator observed that bowls and storage vessel surfaces had dents, scratches and gouges, risking microbial contamination during production.

In addition, the firm did not properly qualify its suppliers of components used for manufacturing. For example, it did not establish that the certificate of analysis was reliable and did not define a frequency for verifying the reliability of a supplier’s analysis.