# FDA 483 - Panacea Biotec Pharma Limited - February 20, 2020

Source: https://www.keypedia.com/records/483/panacea-biotec-pharma-limited/e0b23bbd-c55f-4af2-ad39-81ce377b96da

> FDA 483 for Panacea Biotec Pharma Limited on February 20, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Panacea Biotec Pharma Limited
- Inspection Date: 2020-02-20
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Panacea Biotec Limited, a manufacturer in Baddi, India, was inspected and cited for significant deficiencies across its production and laboratory control systems. Key issues include inadequate environmental monitoring in aseptic processing, lack of proper microbiological contamination prevention procedures, and insufficient production controls for product quality. Furthermore, the firm's laboratory controls exhibited multiple failures in test procedures, record-keeping, and validation of sterilization and testing methods.

## Related Documents

- [483 - 2019-08-09](https://www.keypedia.com/records/483/panacea-biotec-pharma-limited/edf86d66-9618-4be6-9d69-ea03598c921d)
- [WARNING_LETTER - 2020-02-20](https://www.keypedia.com/records/warning_letter/panacea-biotec-pharma-limited/9bfb3b4c-f0cf-4c64-b180-b75c3048009e)
- [483 - 2022-06-08](https://www.keypedia.com/records/483/panacea-biotec-pharma-limited/395ad63f-e1ac-4ea7-a3b0-f736c5a64922)
- [483 - 2023-10-12](https://www.keypedia.com/records/483/panacea-biotec-pharma-limited/1a4dad04-4624-484b-b8e4-dd27e675e850)
- [483 - 2023-10-12](https://www.keypedia.com/records/483/panacea-biotec-pharma-limited/41b98f75-e670-4eb2-9e68-fd30560f426f)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)
- [Philip F. Istafanos](https://www.keypedia.com/people/philip-f-istafanos/c2fcfe52-1070-4551-bffc-f8bcfad5b30b)

Company: https://www.keypedia.com/companies/panacea-biotec-pharma-limited/47335546-7299-440b-8c05-623c8b44b99b

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