# FDA 483 - Panacea Biotec Pharma Limited - October 12, 2023

Source: https://www.keypedia.com/records/483/panacea-biotec-pharma-limited/41b98f75-e670-4eb2-9e68-fd30560f426f

> FDA 483 for Panacea Biotec Pharma Limited on October 12, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Panacea Biotec Pharma Limited
- Inspection Date: 2023-10-12
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Panacea Biotec Pharma Limited, a sterile and non-sterile drug manufacturer in Solan, India, received a Form 483 with nine observations. The inspection revealed significant deficiencies in aseptic processing, environmental monitoring, personnel training for visual inspection, and laboratory controls. These issues indicate a lack of robust procedures and oversight to ensure the sterility and quality of drug products.

## Related Documents

- [483 - 2019-08-09](https://www.keypedia.com/records/483/panacea-biotec-pharma-limited/edf86d66-9618-4be6-9d69-ea03598c921d)
- [483 - 2020-02-20](https://www.keypedia.com/records/483/panacea-biotec-pharma-limited/e0b23bbd-c55f-4af2-ad39-81ce377b96da)
- [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)

## Related Officers

- [Investigator](https://www.keypedia.com/people/muna-algharibeh/0f0dbd13-b36a-408d-8e42-4625f8de905d)
- [Drug National Expert](https://www.keypedia.com/people/sandra-a-boyd/c469103a-0917-407a-b9d1-98273358dfeb)

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