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

During an inspection conducted from January 30 to February 2, 2023, the U.S. Food and Drug Administration (FDA) issued a Form 483 observation to Invitron Advanced Analytics Private Limited, a control testing laboratory located in Hyderabad, India. The primary finding concerned significant deficiencies in laboratory records and data integrity practices. Specifically, the inspection revealed that the firm's laboratory records lacked complete documentation of data obtained during testing. Electronic audit trails from a Karl-Fischer titrator system showed numerous uninvestigated system errors, including 'Determination reprocessed,' 'Start Test Error,' and 'Determination error' events occurring between January 2020 and January 2023. For instance, only three out of seven 'Determination error' instances were investigated, and many 'Start Test Error' and 'Determination reprocessed' events were also not investigated. Furthermore, the company's Standard Operating Procedure for Audit Trail Review was found to be inadequate, as it did not address these types of system errors. These observations indicate a failure to maintain complete and accurate laboratory records and adequately investigate data anomalies, which are critical components of regulatory compliance. Invitron Advanced Analytics Private Limited is required to address these deficiencies by implementing thorough corrective and preventive actions to ensure data integrity, proper investigation of system errors, and updated, comprehensive procedures.