# FDA 483 - Exela Pharma Sciences LLC - November 15, 2024

Source: https://www.keypedia.com/records/483/exela-pharma-sciences-llc/60077e2a-4655-4ff7-84ff-713e02f8a6b0

> FDA 483 for Exela Pharma Sciences LLC on November 15, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Exela Pharma Sciences LLC
- Inspection Date: 2024-11-15
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Exela Pharma Sciences LLC received a Form 483 citing numerous deficiencies across its drug manufacturing and 503B outsourcing facilities. Key issues include inadequate investigations into discrepancies and OOS results, failures in maintaining sterile conditions, and deficiencies in laboratory controls, data integrity, and equipment calibration. The firm also lacked proper stability data, personnel training for visual inspection, and compliant labeling for its outsourcing facility drug products.

## Related Documents

- [483 - 2024-11-04](https://www.keypedia.com/records/483/exela-pharma-sciences-llc/bc618c55-02a7-4815-8657-992fe5c2d7e4)
- [483 - 2014-11-21](https://www.keypedia.com/records/483/exela-pharma-sciences-llc/d66b0c30-18ff-483c-9e48-0cd7c7c061c7)
- [483 - 2019-03-29](https://www.keypedia.com/records/483/exela-pharma-sciences-llc/d9a4c4a7-1eb9-418c-958b-e0105fc4cc09)
- [483 - 2019-07-18](https://www.keypedia.com/records/483/exela-pharma-sciences-llc/984bf368-0442-4212-a91a-700be16d89e9)
- [EIR - 2018-12-19](https://www.keypedia.com/records/eir/exela-pharma-sciences-llc/46cd4842-57f4-427d-b5ba-3a0d9b0f1ed1)

## Related Officers

- [Santos E. Camara](https://www.keypedia.com/people/santos-e-camara/18cea942-f6f9-4dec-9ce9-1c01c39009ce)
- [ CSO](https://www.keypedia.com/people/megan-t-ziegler/3e83a317-701a-4e40-bb43-34d294d3448f)
- [Investigator ](https://www.keypedia.com/people/logan-t-williams/a1febf59-970a-4e4e-9c0c-f4ad385582d7)
- [Joan M. Cantellops Figueroa](https://www.keypedia.com/people/joan-m-cantellops-figueroa/f791fcd2-a5d4-41e8-a8f2-96569096b422)
- [Joan Cantellops](https://www.keypedia.com/people/joan-cantellops/fc262236-5a32-40d8-bc37-3e8505badbaa)

Company: https://www.keypedia.com/companies/exela-pharma-sciences-llc/4e6f3b32-adeb-41f4-b9dd-a8e7784569b3

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7