FDA 483 - Unilab Chemicals and Pharmaceuticals Pvt. Ltd. - April 05, 2023

During an inspection conducted from March 27 to April 5, 2023, the FDA identified significant deficiencies at Antylia Scientific, a medical device manufacturer located in Vernon Hills, IL. The inspection, documented in an FDA 483, revealed six observations primarily concerning the company's quality system, failing to meet requirements outlined in 21 CFR Part 820 (Quality System Regulation) and 21 CFR Part 803 (Medical Device Reporting).

Key issues included inadequacies in the company's corrective and preventive action (CAPA) procedures. Specifically, the CAPA process did not consistently ensure actions were verified or validated for effectiveness, nor were all activities and their results adequately documented. Two specific CAPAs were closed without proper effectiveness verification.

Furthermore, Antylia Scientific's complaint handling procedures were found to be deficient. The firm failed to evaluate all complaints to determine if they represented events requiring reporting to the FDA under Medical Device Reporting regulations. Additionally, complaints were not always processed uniformly or in a timely manner, with several remaining open for over 90 days without documented reasons for delay.

Other observations noted a lack of adequate procedures for rework of nonconforming product, specifically regarding re-testing and re-evaluation after rework. Procedures for controlling nonconforming material also lacked defined responsibilities and authority for product disposition. Lastly, process control procedures for manufacturing environmental controls, such as temperature and humidity, were not adequately established, particularly for products with electrical components.

Antylia Scientific is required to address these deficiencies to ensure compliance with federal regulations governing medical device manufacturing and quality systems.