US FDA inspection observations for Dr. Reddy's Laboratories Limited

US FDA inspection observations for Dr. Reddy's Laboratories Limited General Information:

  1. Facility: Dr. Reddy's Laboratories Limited, located in Pydibhimavaram, Ransthalam, Andhra Pradesh, India.
  2. Inspection Dates: July 10, 2025 - July 18, 2025
  3. Type of Establishment: Sterile Drug Manufacturer
  4. Report Issued To: Mr. Shailendra Jha, Site Head

Summary of Observations:

The FDA inspection revealed several observations related to the production and quality systems at Dr. Reddy's Laboratories Limited, indicating potential deviations from established regulations and guidelines.

Observation 1: Microbiological Contamination Prevention Procedures designed to prevent microbiological contamination of drug products purporting to be sterile were not adequately written. Specifically, the SOP for cleaning a vial filling, stoppering, and sealing machine allows the use of non-sterile substances to clean surfaces. The SOP does not prohibit the introduction or use of non-sterile substances during setup activities, nor does it specify if the sanitisation agents are sterile.

Observation 2: Aseptic Process Validation Procedures designed to prevent microbiological contamination of drug products did not include adequate validation of the aseptic process. Smoke studies conducted on July 17, 2025, used to manufacture sterile drug products for U.S. distribution, exhibited poor visualisation due to inadequate smoke generation. This raised concerns about ensuring unidirectional airflow to protect exposed sterile stoppers.

Observation 3: Laboratory Testing and Release Testing and release of drug products did not include appropriate laboratory determination of satisfactory conformance to final specifications. Visual inspection of drug products found that visual inspectors are failing to rotate vials appropriately, and rolling vials in gloved hands also does not provide adequate contrast.

Observation 4: Equipment Size and Suitability. The equipment used in manufacturing, processing, or packing drug products was not of adequate size to facilitate operations for its intended use. The System (Equipment) used in the compounding process of injection products was not qualified to verify its capacity, which is essential for larger commercial-scale manufacturing.

Observation 5: In-Process Material Testing Examination and testing of samples were not performed to ensure that in-process materials conform to specifications. The in-process bulk (possibly API, this part is redacted) during the compounding process of manufacturing Injection mg/vial was identified as a critical process parameter (CPP), but it was not measured properly. 

There is no sensor, or it seems that the sensor will no longer be in contact with the product.

Observation 6: Quality Control Review. Drug product production and control records were not reviewed and approved by the quality control unit to determine compliance with all established procedures before batch release. Air plates used to monitor the Grade A environment were read by a microbiologist, and while a supervisor verified microbial counts, the supervisor failed to document the readings in the LIMS.

Observation 7: Discrepancy Review and CAPA Effectiveness. There was a failure to review unexplained discrepancies thoroughly, and corrective and preventative actions (CAPA) were not properly checked for effectiveness or adequacy to prevent recurrence.

  • Deviation 200431248: A Grade A excursion led to a CAPA involving cleaning of the equipment (the name is redacted) with a wipe and visual checks.
  • OOS Investigations: Recurring OOS notifications for one injection product were not addressed with adequate preventive actions to mitigate the risk of failure modes.
  • Deviation 20041971: A training module for capping machine alignment was created but failed to implement the improved setup instruction in the equipment SOP.
  • Deviation 200424689: Critical rejects exceeded specifications for a drug product; however, the intended BMR prepared in Sep 2024 for proposed commercial batches did not implement the in-process changes as per CAPA.

These observations highlight potential areas of concern in the manufacturing and quality control processes at Dr. Reddy's Laboratories. It indicates a need for improvements in documentation, process validation, equipment suitability, data integrity, and the effectiveness of corrective actions.

Although the exact list of products manufactured at the Pydibhimavaram sterile site is not publicly available, it is highly likely that the site is producing bendamustine intravenous 25 mg/vial and 100 mg/vial products. 



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