Neuland Laboratories Limited (Unit II) – FDA 483, Feb 7, 2020

On February 3-7, 2020, the FDA inspected Neuland Laboratories Limited (Unit II), an API Manufacturer located in Isnapur Village, Patancheru Mandal, Sangareddy, TS, India. The inspection, led by Investigator Nadeem I. Chaudhry, resulted in a Form FDA 483 being issued to Sucheta Rao Davuluri, Vice Chairman and Chief Executive Officer.

Two observations were noted:

1. **Equipment Cleaning Deficiency:** Equipment was not effectively cleaned to prevent contamination. Specifically, black sticky material, identified as leftover grease, was found inside a [6][4] machine [6][4][8][8] that was declared as "ready to be cleaned" based on procedures. This indicates a failure to prevent contamination that could alter the safety, identity, strength, quality, or purity of the drug product.

2. **Inadequate or Absent Written Procedures:** * **Computerized Systems Protection:** Written procedures for the operation and maintenance of computerized systems lacked sufficient detail regarding automatic fire suppression and shock prevention for servers. Furthermore, servers used for electronic data backup and storage (Empower-3, Lab-solution, and other stand-alone instruments) were not adequately protected against fire and physical shock. * **Personnel Hygiene and Gowning:** There were no written procedures or physical mechanisms for hand cleaning/sanitization at the entry to material dispensing and sampling areas (Grade-