FDA 483 - Apitoria Pharma Private Limited - December 17, 2024

Aptoria Pharma Private Limited, Unit-V, located in Patancheru Mandal, India, received an FDA Form 483 citing significant deficiencies. The inspection revealed inadequate validation of aseptic processes for sterile drug substances, including issues with media fill studies and disinfectant efficacy. Additionally, the firm failed to conduct annual visual examinations of reserve samples for deterioration.