Neuland Laboratories Limited – FDA 483, Feb 7, 2020

Neuland Laboratories Limited, an API manufacturer located in Isanpur Village, Patancheru Mandal, Sangareddy, TS, India, underwent an FDA inspection from February 3 to February 7, 2020. The inspection revealed significant compliance issues that require immediate attention.

Key violations included inadequate cleaning of equipment, which poses a risk of contamination affecting the drug product's safety, identity, strength, quality, or purity. Specifically, a black sticky material, identified as leftover grease, was found inside a machine that was declared clean. This indicates a failure in the cleaning procedures.

Additionally, the firm lacked comprehensive written procedures for critical operations. The procedures for operating and maintaining computerized systems did not adequately address fire suppression and shock prevention mechanisms for servers. These servers, crucial for electronic data backup and storage, were not sufficiently protected against fire and physical shock.

Furthermore, there were no established procedures for hand cleaning or sanitization at the entry points of material dispensing and sampling areas (Grade-D), leading to potential contamination risks. The absence of interlock areas for gowning further exacerbates this issue, as employees enter sensitive areas with outside clothing.

Neuland Laboratories Limited is required to address these deficiencies by implementing corrective actions to ensure compliance with FDA regulations. This includes revising cleaning protocols, establishing comprehensive written procedures for system operations, and enhancing protective measures for sensitive areas within the facility.