# FDA 483 - Jubilant Cadista Pharmaceuticals, Inc. - January 15, 2025

Source: https://www.keypedia.com/records/483/jubilant-cadista-pharmaceuticals-inc/403f140d-62c8-42a5-a928-0a915fcfd306

> FDA 483 for Jubilant Cadista Pharmaceuticals, Inc. on January 15, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jubilant Cadista Pharmaceuticals, Inc.
- Inspection Date: 2025-01-15
- Product Type: drugs
- Office Name: Baltimore District Office
- Summary: An FDA inspection of Jubilant Cadista Pharmaceuticals, Inc. in Salisbury, MD, conducted from January 8-15, 2025, identified several deficiencies in their human drug manufacturing operations. The findings, presented as a Form FDA 483, primarily concerned manufacturing controls, record-keeping, and compliance with the Drug Supply Chain Security Act (DSCSA). Key issues included the absence of independent second-person verification for critical film coating process parameters in master production records, with equipment not providing electronic raw data. Furthermore, requested production batch records were not readily available for review during the inspection. The company also failed to properly quarantine rejected in-process materials, specifically quantities of Losartan potassium and Hydrochlorothiazide tablets. Significant shortcomings were noted in DSCSA compliance, as the firm lacked written procedures for handling suspect and illegitimate products, notification protocols, sample retention, disposition, termination notifications, and record-keeping for product identifiers and investigations. Lastly, batch production records for several drug products were deficient, lacking full identification for individuals performing, supervising, and checking significant operational steps. Jubilant Cadista is required to address these observations with comprehensive corrective actions to ensure compliance with regulatory standards.

## Related Documents

- [483 - 2020-02-28](https://www.keypedia.com/records/483/jubilant-cadista-pharmaceuticals-inc/fdf3097d-13b9-416c-ba5e-0b1cc12c2ece)
- [483 - 2025-01-15](https://www.keypedia.com/records/483/jubilant-cadista-pharmaceuticals-inc/17fffb31-9369-447f-88f9-03a0e7265a40)

## Related Officers

- [FDA_PERSONNEL](https://www.keypedia.com/people/avinash-ghumatkar/9d95e31c-5acb-4e2c-a54a-a39f155bb1ba)
- [Investigator](https://www.keypedia.com/people/pushpa-s-jayasekara/cfd7d22f-b4c2-4002-ae18-b5435815d27d)

Company: https://www.keypedia.com/companies/jubilant-cadista-pharmaceuticals-inc/bf3fdb52-1211-4c3c-8e41-659d9e4e13f9

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa