The US FDA has issued a Form 483 to Natco Pharma after an inspection of the biopharma’s API manufacturing facility in Hyderabad, India. The inspection, which was conducted between August 5th and 9th, 2019 made 6 observations. According to the company, most of the observations were procedural in nature including gowning, revalidation and approval process for alternate suppliers. Other notable observations by FDA inspectors included stains in some early stage reactors that had not been adequately investigated and missing ‘status tags’ on certain equipment used in the drying process. Learn More