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483
•Exela Pharma Sciences LLC•November 4, 2024

Exela Pharma Sciences LLC – FDA 483, Nov 4, 2024

Record Details

The provided document consists almost entirely of redacted information, indicated by '(b) (4)' markings. Consequently, specific details such as the company name, inspection dates, main violations or issues observed, and any required actions cannot be extracted. The unredacted portions only describe the general purpose of an FDA Form 483 and cite Section 704(b) of the Federal Food, Drug and Cosmetic Act (21 USC 374(b)). This section outlines that inspectors report conditions or practices indicating products may be adulterated or prepared under insanitary conditions. Without the specific details that have been redacted, a summary addressing the company, inspection specifics, and particular findings cannot be generated.

Company
Exela Pharma Sciences LLC
Inspection date
November 4, 2024
Office
Atlanta District Office
People
  • Megan T. Ziegler ( CSO)
  • Logan T. Williams (Investigator )
  • Santos E. Camara
  • Joan Cantellops
  • Joan M. Cantellops Figueroa
View Company Profile

ID · 5de8eeaa-193a-42b9-94b5-06662a319921

Violation Codes1
21 CFR 211.192

Full citation text and observation details available on the Dashboard.

Other documents for Exela Pharma Sciences LLC
  • WARNING_LETTER - 2024-11-15November 15, 2024
  • EIR - 2019-10-22October 22, 2019
  • EIR - 2019-07-18July 18, 2019
  • 483 - 2019-07-18July 18, 2019
  • WARNING_LETTER - 2019-07-18July 18, 2019

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