CGMP Violations Found at India Facility

FDA sent a warning letter, dated April 24, 2018, to Goran Pharma Private Limited after an inspection of the company’s Sihor, Gujarat, India facility found deviations from current good manufacturing practices (CGMPs). A variety of violations found during the inspection included failure to identify ingredients from suppliers, inadequate quality control, and inappropriate equipment use. The inspection was conducted by FDA from Nov. 13–15, 2017.

Specifically, FDA stated in the warning letter that the company failed to test components from suppliers to “determine their conformance to identity, purity, strength, and other appropriate specifications. Your firm released components for use in drug product manufacturing based on certificates of analysis (COA) from your supplier without establishing the reliability of the suppliers’ analyses through appropriate validation.”

The agency requested the company provide a detailed description of how it plans on ensuring that components used in manufacturing be withheld from use until they have been tested. The company must also show how it will quality suppliers’ COAs, perform detailed risk assessments, and do a comprehensive review of laboratory practices, methods, equipment, and analyst competencies.

The warning letter also indicated that the company’s response to inspectors finding that inappropriate systems were used was lacking. The agency requested the company provide a detailed validation plan for its new system, procedures for routine monitoring of the system, a risk assessment of product manufactured on the old system, and reasons for why the company relied on past data to characterize the system’s state of control.

Inadequate control of air pressure, micro-organisms, dust, humidity, and temperature was also observed by inspectors. The agency requested the company provide an action plan for ensuring control and monitoring of temperature, humidity, and air cleanliness as well as an independent assessment of the company’s facilities and equipment.

The warning letter stated that FDA had placed the firm on Import Alert 66-40 on March 5, 2018.

FDA recommended the company hire a third-party CGMP consultant to audit the company’s operations.

Source: FDA