FDA 483 - Gland Pharma Limited, Units I+II Pashamylaram Site - August 02, 2024

This FDA Form 483 document details observations from an inspection, highlighting deficiencies in aseptic processing, environmental monitoring, and quality control at an unnamed facility.

**Observation 1** addresses the lack of established, written, and followed procedures to prevent microbiological contamination of sterile drug products. Specifically, Aseptic Processing Simulations (Media Fills) are deficient. The procedure SOP QA-0020-009, effective May 31, 2024, does not require tracking and trending of all types and durations of interventions during aseptic process simulations and actual finished product filling. An example cited is the unrecorded transfer and opening of stopper bags via a mobile LAF cart and RABS cabinet, involving movement through a Grade B room, with no record of the process between.

**Observation 2** notes deficiencies in the system for monitoring environmental conditions in aseptic processing areas. Procedure PD-0077-010, "Performing of Filling Interventions," does not prohibit operators from sanitizing the RABS with sterile solution prior to receiving a finger dab. An example provided is an operator performing setup activities for "Injection, USP, Batch #" and then sanitizing the RABS with sterile solution before a finger dab.

**Observation 3** indicates that the responsibilities and procedures of the quality control unit are not in writing and fully followed. The firm reported 22 of 46 deviations in 2023 for aseptic filling line breakdowns