FDA 483 - EUGIA Pharma Specialities Limited - March 06, 2018

During an FDA inspection, the facility was cited for several violations related to its production and process controls, personnel training, and laboratory control mechanisms.

**Production and Process Controls:** The firm lacks written procedures to ensure drug product identity, strength, quality, and purity. Specifically, the Vial Sealing Machine (PF/VSM-01) has an unsubstantiated operating speed range of REDACTED vials per minute in manufacturing batch records. The worst-case speed of REDACTED vials per minute was never processed during development or validation.

**Personnel Training:** Employees involved in manufacturing, processing, packing, and holding drug products lack adequate training for their assigned functions. The visual inspection qualification procedure (SOP#PPT-07) is insufficient. The training kit for 100% visual inspection of sterile drug products only contains REDACTED glass vial with REDACTED particulate and REDACTED glass vial with a large REDACTED particulate, failing to challenge inspectors with the full range of potential contamination.

**Laboratory Control Mechanisms:** The establishment and changes to laboratory control mechanisms are not drafted by the appropriate organizational unit. The REDACTED Microbial Identification System (QC/VMI-01), installed on 01/10/2011 with REDACTED SW version REDACTED, underwent undocumented software updates from REDACTED to REDACTED, and then from REDACTED to REDACTED on 18/06/20