# FDA 483 - Cronus Pharma Specialities India Pvt Ltd - August 29, 2023

Source: https://www.keypedia.com/records/483/cronus-pharma-specialities-india-pvt-ltd/35e13b0e-5045-4ced-8827-a9a1b50227b0

> FDA 483 for Cronus Pharma Specialities India Pvt Ltd on August 29, 2023. Product: veterinary. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cronus Pharma Specialities India Pvt Ltd
- Inspection Date: 2023-08-29
- Product Type: veterinary
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Cronus Pharma Specialities India Pvt Ltd in Hyderabad, India, a sterile injectable veterinary drug manufacturer, revealed two significant observations. The firm was cited for inadequate controls over computer systems, including lack of performance qualification and audit trails for critical equipment, and deficiencies in its quality control unit's responsibilities, specifically regarding employee training documentation and assessment. These issues indicate a need for improved data integrity and quality system oversight.

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## Related Officers

- [Investigator ](https://www.keypedia.com/people/nicole-e-knowlton/8e65400f-249f-45fe-96fc-cb00fec6ae39)
- [Lillian S. Wu](https://www.keypedia.com/people/lillian-s-wu/b1f6643c-ac01-43e5-8ce2-e6f4fdba9d35)

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-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1