# FDA 483 - Exela Pharma Sciences LLC - November 04, 2024

Source: https://www.keypedia.com/records/483/exela-pharma-sciences-llc/bc618c55-02a7-4815-8657-992fe5c2d7e4

> FDA 483 for Exela Pharma Sciences LLC on November 04, 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: 2024-11-04
- Product Type: Drugs
- Office Name: Division of Human and Animal Food Operations - East III
- Summary: The provided FDA 483 document is almost entirely redacted, making it impossible to create a specific summary including the company name, inspection dates, main violations, or required actions. The only visible content explains the general purpose of an FDA Form 483, stating that observations of objectionable conditions or practices are reported pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act. This section outlines that inspectors report conditions indicating a product is adulterated or prepared, packed, or held under insanitary conditions that could lead to contamination or injury to health. Without the specific details of the observations, a concise summary of this particular document's findings cannot be generated.

## Related Documents

- [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)
- [WARNING_LETTER - 2024-11-15](https://www.keypedia.com/records/warning_letter/exela-pharma-sciences-llc/832d5d8c-294f-4c3e-9653-35170b74e857)

## 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)
- [Vice President Clinical and Regulatory Affairs](https://www.keypedia.com/people/aruna-koganti/4760c049-6d4b-46a4-94fb-477afd8708ed)
- [Investigator ](https://www.keypedia.com/people/logan-t-williams/a1febf59-970a-4e4e-9c0c-f4ad385582d7)
- [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/division-of-human-and-animal-food-operations-east-iii/fe10072a-a5ee-4949-9781-1942c4334ab7