FDA 483 - Neuland Laboratories Limited (Unit II) - February 07, 2020

This FDA Form 483 was issued to NEULAND LABORATORIES LIMITED (Unit II), an API Manufacturer located in Isnapur Village, Patancheru Mandal, Sangareddy, TS, India, following an inspection from February 3-7, 2020. The report was addressed to Sucheth Rao Davuluri, Vice Chairman and Chief Executive Officer.

Two observations were made:

1. **Equipment Cleaning Deficiency:** Black sticky material, identified as leftover grease, was found inside the (b)(4) machine (b)(4)18, which was declared as "ready to be cleaned." This indicates that equipment was not effectively cleaned to prevent contamination that could alter the safety, identity, strength, quality, or purity of the drug product.

2. **Inadequate Written Procedures:** * Written procedures for computerized systems lacked sufficient detail regarding automatic fire suppression and shock prevention mechanisms for servers (Empower-3, Lab-solution, and other stand-alone instruments). These servers, used for electronic data backup and storage, were not adequately protected against fire and physical shock. * No written procedures existed for hand cleaning/sanitization at the entry of material dispensing and sampling areas (Grade-D) in the firm’s warehouse. Furthermore, no hand cleaning/sanitization mechanisms were provided at these entries. There were also no interlock areas for donning gowns, head, mouth, and shoe covers, allowing