Exela Pharma Sciences, LLC
FDA inspection history across 2 sites, 2014 to 2025
- 6
- Form 483s
- 2
- Warning letters
- 1
- Close-out
- 1
- Untitled letter
Every document, by year
- Warning letter
- Form 483
- Close-out
- Untitled letter
2014: one Form 483; 2016: one untitled letter; 2017: one Form 483; 2019: two Form 483s; 2021: one close-out letter and one warning letter; 2024: two Form 483s; 2025: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–21Four Form 483s, one untitled letter, one close-out letter and one warning letter, at Lenoir, Georgia and Lenoir, North Carolina.
- 2024–25Two Form 483s and one warning letter, at Lenoir, North Carolina.
- 2024The longest 483 on file: 15 observations over 19 pages at Lenoir, North Carolina.
Cited most
Across all Exela Pharma Sciences observations on file
- 21 CFR 211.113Control of microbiological contamination8
- 21 CFR 211.42Design and construction features7
- 21 CFR 211.194Laboratory records4
- 21 CFR 211.68Automatic, mechanical, and electronic equipment4
- 21 CFR 211.80General requirements4
The complete Exela Pharma Sciences file.
All 10 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
25% off buying them one by one
Sites
Lenoir, North Carolina
Five Form 483s, two warning letters, one close-out letter and one untitled letter · 2016 to 2025 · 53 observations
Latest: Warning letter, Jul 2, 2025 →Lenoir, Georgia
One Form 483 · 2014 · 1 observation
Latest: Form 483, Nov 21, 2014 →
Documents
10 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-07-02 | Warning letter Warning letter | Lenoir, North Carolina | — | $99 |
| 2024-11-15 | 483 Form 483 | Lenoir, North Carolina | 15 | $99 |
| 2024-11-04 | 483 Form 483 | Lenoir, North Carolina | 15 | $99 |
| 2021-04-30 | Close-out Close-out letter | Lenoir, North Carolina | — | $99 |
| 2021-04-08 | Warning letter Warning letter | Lenoir, North Carolina | — | $99 |
| 2019-07-18 | 483 Form 483 | Lenoir, North Carolina | 7 | $99 |
| 2019-03-29 | 483 Form 483 | Lenoir, North Carolina | 10 | $99 |
| 2017-09-28 | 483 Form 483 | Lenoir, North Carolina | 6 | $99 |
| 2016-04-28 | Untitled letter Untitled letter | Lenoir, North Carolina | — | $99 |
| 2014-11-21 | 483 Form 483 | Lenoir, Georgia | 1 | $99 |
Investigators on these documents
Santos E. Camara (2)Joan Cantellops (2)Logan T. Williams (2)Megan Ziegler (2)Samantha J. Bradley (2)Brett Weed (1)Ev Lin (1)Jason R. Caballero (1)Noreen Muniz (1)Rachael Moliver (1)
FEI number 3008563008 · most recent document Jul 2, 2025
About Exela Pharma Sciences, LLC
How many FDA Form 483s has Exela Pharma Sciences, LLC received?
FDA Intel has 6 Form 483s on file for Exela Pharma Sciences, LLC; the most recent is dated Nov 15, 2024.
When was Exela Pharma Sciences, LLC last inspected by FDA?
The most recent FDA inspection document on file for Exela Pharma Sciences, LLC is a Form 483 dated Nov 15, 2024, for the site in Lenoir, North Carolina.
What did FDA cite at Exela Pharma Sciences, LLC?
The regulations cited most in the observations on file for Exela Pharma Sciences, LLC are 21 CFR 211.113 (Control of microbiological contamination), 8 times; 21 CFR 211.42 (Design and construction features), 7 times; 21 CFR 211.194 (Laboratory records), 4 times.
Has Exela Pharma Sciences, LLC received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Exela Pharma Sciences, LLC; the most recent is dated Jul 2, 2025.
Has Exela Pharma Sciences, LLC received an FDA untitled letter?
Yes. FDA Intel has 1 FDA untitled letter on file for Exela Pharma Sciences, LLC; the most recent is dated Apr 28, 2016. An untitled letter is FDA's enforcement letter for violations that don't rise to warning-letter level.