# FDA 483 - Panacea Biotec Pharma Limited - August 09, 2019

Source: https://www.keypedia.com/records/483/panacea-biotec-pharma-limited/edf86d66-9618-4be6-9d69-ea03598c921d

> FDA 483 for Panacea Biotec Pharma Limited on August 09, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Panacea Biotec Pharma Limited
- Inspection Date: 2019-08-09
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Panacea Biotec Limited, a drug manufacturer in Baddi, India, was inspected by the FDA from August 5-9, 2019. The inspection revealed significant issues with change control procedures, specifically regarding the scientific justification for changes to production processing parameters. Additionally, the firm failed to implement corrective and preventive actions identified during drug complaint investigations.

## Related Documents

- [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)
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## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)

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