FDA 483 - Invitron Advanced Analytics Private Limited - February 02, 2023

An FDA inspection of Invitron Advanced Analytics Private Limited's Control Testing Laboratory in Hyderabad, India, identified significant deficiencies in laboratory records. The firm failed to maintain complete data from electronic audit trails and did not adequately investigate repeated system errors from its Karl-Fischer titrator. These issues raise concerns regarding data integrity and the effectiveness of the firm's quality control processes.