# FDA 483 - Torrent Pharmaceuticals Limited - December 11, 2023

Source: https://www.globalkeysolutions.net/records/483/torrent-pharmaceuticals-limited/b5da81d7-8b10-4853-b9dd-786cae23215e

> FDA 483 for Torrent Pharmaceuticals Limited on December 11, 2023. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Torrent Pharmaceuticals Limited
- Inspection Date: 2023-12-11
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection conducted at Torrent Pharmaceuticals Limited Unit - 2 in Chiat, Gujrat, India, from December 5 to December 11, 2023, resulted in a Form FDA 483, detailing significant deviations from Good Manufacturing Practices. The inspection uncovered critical issues across several key operational systems.  Within the Quality System, the firm failed to thoroughly investigate unexplained discrepancies, such as out-of-specification results for product tests, often invalidating them without scientific justification or implementing appropriate corrective actions. Procedures for quality control were not consistently followed, including the absence of performance qualifications for key equipment, inadequate calibration programs, and unestablished methods for calculating and rounding microbial counts. Additionally, critical filter integrity testing was overlooked, and manufacturing alarms were not properly documented or investigated. Deficiencies in Facilities and Equipment included a lack of cleaning validation for glassware washers, the use of undefined cleaning agents, and observing unsanitary conditions like mildew, rust, and dirt in an incubator used for microbial plates. Worn gaskets in a capsule filling machine also indicated poor maintenance. The Production System showed a failure to define and record critical component amounts in batch manufacturing records. Lastly, the Laboratory Control System lacked established accuracy, sensitivity, specificity, and reproducibility for various test methods, indicating inadequate method validation or verification. These observations highlight a systemic breakdown in maintaining control over quality, manufacturing processes, and laboratory operations. Torrent Pharmaceuticals is required to thoroughly address these findings with comprehensive corrective and preventive actions to ensure compliance with regulatory standards and safeguard product quality and patient safety.

## Related Documents

- [483 - 2023-12-11](https://www.globalkeysolutions.net/records/483/torrent-pharmaceuticals-limited/8aec8954-11d2-499d-9063-1cc79c1c2c4c)

## Related Officers

- [Yvins Dezan](https://www.globalkeysolutions.net/people/yvins-dezan/e9fd12e6-c090-4eb6-bc78-8b80e8a90946)

Company: https://www.globalkeysolutions.net/companies/torrent-pharmaceuticals-limited/f6a46248-6051-4cd6-8fa4-220f0a33652c

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6