FDA 483 - Agon Pharma Private Ltd - June 13, 2019

Agon Pharma Pvt. Ltd. in Pune, Maharashtra, India, was cited with four observations during an FDA inspection regarding significant deficiencies in their manufacturing controls. These issues included inadequate batch production records, improper identification of raw materials and in-process equipment, and a failure to follow change control procedures for facility modifications. The findings indicate a lack of adherence to established quality assurance and production control standards.