# FDA 483 - CIRON DRUGS AND PHARMACEUTICALS PVT LTD - September 21, 2022

Source: https://www.globalkeysolutions.net/records/483/ciron-drugs-and-pharmaceuticals-pvt-ltd/70c9f802-e981-4d71-b96f-b35a409ae2d1

> FDA 483 for CIRON DRUGS AND PHARMACEUTICALS PVT LTD on September 21, 2022. 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: 2022-09-21
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Ciron Drugs and Pharmaceuticals Private Limited, a sterile drug manufacturer in Tarapur, India, received an FDA Form 483 citing significant deficiencies during an inspection. The observations primarily focused on inadequate environmental monitoring in aseptic processing areas, insufficient equipment controls for microorganisms, and a lack of established procedures to prevent microbiological contamination. Additionally, the firm's laboratory controls for handling out-of-specification results were found to be scientifically unsound.

## Related Documents

- [483 - 2023-04-25](https://www.globalkeysolutions.net/records/483/ciron-drugs-and-pharmaceuticals-pvt-ltd/fd6e895e-4745-40d2-bd99-b1223a5edeb9)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/michael-a-charles/f83241f0-ae3b-4535-ac03-e790bbf666ca)

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