# FDA 483 - CIRON DRUGS AND PHARMACEUTICALS PVT LTD - April 25, 2023

Source: https://www.globalkeysolutions.net/records/483/ciron-drugs-and-pharmaceuticals-pvt-ltd/fd6e895e-4745-40d2-bd99-b1223a5edeb9

> FDA 483 for CIRON DRUGS AND PHARMACEUTICALS PVT LTD on April 25, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CIRON DRUGS AND PHARMACEUTICALS PVT LTD
- Inspection Date: 2023-04-25
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Ciron Drugs and Pharmaceuticals Private Limited, a manufacturer in Tarapur, India, received a Form 483 for two significant observations. The firm's aseptic process validation was deemed inadequate due to an incomplete disinfectant efficacy study. Additionally, in-process materials were not properly tested, and bulk hold time studies were deficient, lacking critical documentation and stability evaluations for finished drug products.

## Related Documents

- [483 - 2022-09-21](https://www.globalkeysolutions.net/records/483/ciron-drugs-and-pharmaceuticals-pvt-ltd/70c9f802-e981-4d71-b96f-b35a409ae2d1)

## Related Officers

- [Bijoy Panicker](https://www.globalkeysolutions.net/people/bijoy-panicker/1c6ec57f-e02e-49b8-8b59-1853f3d2947a)

Company: https://www.globalkeysolutions.net/companies/ciron-drugs-and-pharmaceuticals-pvt-ltd/102d0195-96e9-439a-b814-33ed206bbc6b

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1