# FDA 483 - Exela Pharma Sciences LLC - March 29, 2019

Source: https://www.keypedia.com/records/483/exela-pharma-sciences-llc/d9a4c4a7-1eb9-418c-958b-e0105fc4cc09

> FDA 483 for Exela Pharma Sciences LLC on March 29, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Exela Pharma Sciences LLC
- Inspection Date: 2019-03-29
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Exel B Pharma Sciences LLC, a sterile drug manufacturer in Lenoir, NC, received ten observations during an FDA inspection. The firm was cited for significant data integrity deficiencies in laboratory controls and equipment, inadequate environmental monitoring and cleaning in aseptic processing areas, and incomplete batch production records. Additional issues included lacking material identification procedures, improper product storage, insufficient facility space, poorly controlled equipment logs, and inadequate employee training.

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## Related Officers

- [ Drug Investigator](https://www.keypedia.com/people/samantha-j-bradley/ba45f64f-07a9-4933-833f-b9b339c57783)
- [Jason R. Caballero](https://www.keypedia.com/people/jason-r-caballero/c2c8d281-0d02-459f-9541-bc04cb6d0a59)

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