# FDA 483 - Panacea Biotec Pharma Limited - June 08, 2022

Source: https://www.keypedia.com/records/483/panacea-biotec-pharma-limited/395ad63f-e1ac-4ea7-a3b0-f736c5a64922

> FDA 483 for Panacea Biotec Pharma Limited on June 08, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Panacea Biotec Pharma Limited
- Inspection Date: 2022-06-08
- 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 Baddi, India, was cited for significant deficiencies during an FDA inspection. The observations highlight critical failures in aseptic processing, environmental monitoring, data integrity, and quality control, particularly concerning the prevention of microbiological contamination and the thoroughness of out-of-specification investigations. These issues collectively indicate a lack of adequate controls to ensure the sterility and overall 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 - 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

- [Wayne D. Mcgrath](https://www.keypedia.com/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)
- [Cynthia Jim](https://www.keypedia.com/people/cynthia-jim/e0f1c8a7-d787-442a-911c-61e37cd806a6)

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