FDA 483 - Aktinos Pharma Pvt. Ltd. - November 01, 2018

During an inspection conducted from October 29 to November 1, 2018, the FDA issued a Form 483 to Aktinos Pharma Pvt. Ltd., an intermediate manufacturer in Visakhapatnam, India. The inspection identified significant deviations from current Good Manufacturing Practices (cGMP).

Key observations included deficiencies across multiple systems. The laboratory system lacked validation for in-house analytical methods used for intermediate product release and cleaning verification. In the production system, there were issues with inadequate control procedures, such as the absence of statistically sound sampling plans, insufficient hold time studies for in-process materials, and a lack of second-person verification for raw material dispensing.

The firm also failed to validate cleaning procedures for non-dedicated manufacturing equipment. Furthermore, the quality system exhibited weaknesses, including inadequate investigation and documentation of out-of-specification results, alongside a failure by the Quality Unit to maintain robust procedures for supplier qualification and change control management. Lastly, significant employee training deficiencies were noted, particularly concerning cGMP and the implementation of corrective actions for quality events.

Aktinos Pharma Pvt. Ltd. is required to submit a comprehensive response detailing corrective and preventive actions to address these observations and ensure compliance with regulatory standards.