# FDA 483 - Cronus Pharma Specialities India Pvt Ltd - January 15, 2022

Source: https://www.keypedia.com/records/483/cronus-pharma-specialities-india-pvt-ltd/33bfd2d9-3d92-4840-b8d8-8ef88698f434

> FDA 483 for Cronus Pharma Specialities India Pvt Ltd on January 15, 2022. 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: 2022-01-15
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: This FDA Form 483 report details significant deficiencies at Cronus Pharma Specialities India Pvt Ltd concerning the manufacture of sterile and non-sterile injectable drug products. Observations highlight inadequate process and cleaning validation, failures in preventing microbiological contamination, and a lack of robust quality control unit oversight. These issues collectively pose a high risk to product quality, safety, and efficacy.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/kellia-n-hicks/44104c4a-70c1-47fc-9a77-c09c41bacc2b)

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

Office: https://www.keypedia.com/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4