FDA 483 - Global Calcium Pvt. Limited - February 22, 2019

The FDA inspected Global Calcium Pvt. Limited in Hosur, India, an API manufacturer, and issued a Form 483. The inspection revealed significant deficiencies in the firm's product quality complaint investigation process, including the failure to consistently request and test return product samples. Additionally, the firm demonstrated inadequate control over loose GMP documents, issues with equipment cleaning verification, and a lack of adequate training for employees handling product quality complaints.