# FDA 483 - Cronus Pharma Specialities India Pvt Ltd - August 20, 2025

Source: https://www.keypedia.com/records/483/cronus-pharma-specialities-india-pvt-ltd/29622c0b-f177-4aae-b285-cfafed1af44f

> FDA 483 for Cronus Pharma Specialities India Pvt Ltd on August 20, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cronus Pharma Specialities India Pvt Ltd
- Inspection Date: 2025-08-20
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: An FDA inspection of Cronus Pharma Specialities India Pvt Ltd in Hyderabad revealed significant deficiencies in their manufacturing of large volume parenteral drug products. Observations included poor facility maintenance with contamination risks, inadequate written procedures for contamination control, and failures in quality control unit responsibilities, including product complaint handling and media fill documentation. Additionally, the firm lacked proper controls for manufacturing process validation, visual inspection operator qualification, and computer system access, indicating a broad range of GMP non-compliance.

## Related Documents

- [483 - 2022-01-15](https://www.keypedia.com/records/483/cronus-pharma-specialities-india-pvt-ltd/33bfd2d9-3d92-4840-b8d8-8ef88698f434)
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## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/rajiv-r-srivastava/05b42bfd-0cf4-42ce-89e1-b81bf36eaa17)
- [Laura S. Huffman](https://www.keypedia.com/people/laura-s-huffman/13973f9f-7c20-4a9a-bdbe-a973cfaacec6)
- [Adam M. Derr](https://www.keypedia.com/people/adam-m-derr/50bf32ff-1fa0-453c-8b34-8a693f980bed)

Company: https://www.keypedia.com/companies/cronus-pharma-specialities-india-pvt-ltd/5eba515d-716e-4acb-b927-57e4973bb0c4

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3