Acella Pharmaceuticals, LLC
FDA inspection history in Alpharetta, Georgia, 2019 to 2024
- 5
- Form 483s
- 1
- Close-out
Every document, by year
- Form 483
- Close-out
2019: one Form 483; 2020: one close-out letter and one Form 483; 2021: one Form 483; 2023: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–24Five Form 483s and one close-out letter, at Alpharetta, Georgia.
- 2021The longest 483 on file: 5 observations over 7 pages at Alpharetta, Georgia.
Cited most
Across all Acella Pharmaceuticals observations on file
- 21 CFR 211.192Production record review4
- 21 CFR 211.198Complaint files4
- 21 CFR 211.22Responsibilities of quality control unit3
- 21 CFR 314.80Postmarketing reporting of adverse drug experiences3
- 21 CFR 314.81Other postmarketing reports2
The complete Acella Pharmaceuticals file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Alpharetta, Georgia
Five Form 483s and one close-out letter · 2019 to 2024 · 17 observations
Latest: Form 483, Dec 18, 2024 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-12-18 | 483 Form 483 | Alpharetta, Georgia | 3 | $99 |
| 2023-02-10 | 483 Form 483 | Alpharetta, Georgia | 4 | $99 |
| 2021-09-17 | 483 Form 483 | Alpharetta, Georgia | 5 | $99 |
| 2020-08-14 | Close-out Close-out letter | Alpharetta, Georgia | — | $99 |
| 2020-01-07 | 483 Form 483 | Alpharetta, Georgia | 3 | $99 |
| 2019-03-29 | 483 Form 483 | Alpharetta, Georgia | 2 | $99 |
Investigators on these documents
Veronica Fuentes (3)Cayie Gicleon (1)Jessica M. Simpson (1)Song Y. Lavalais (1)Vanessa E. Coulter (1)
FEI number 3006691461 · most recent document Dec 18, 2024
About Acella Pharmaceuticals, LLC
How many FDA Form 483s has Acella Pharmaceuticals, LLC received?
FDA Intel has 5 Form 483s on file for Acella Pharmaceuticals, LLC; the most recent is dated Dec 18, 2024.
When was Acella Pharmaceuticals, LLC last inspected by FDA?
The most recent FDA inspection document on file for Acella Pharmaceuticals, LLC is a Form 483 dated Dec 18, 2024, for the site in Alpharetta, Georgia.
What did FDA cite at Acella Pharmaceuticals, LLC?
The regulations cited most in the observations on file for Acella Pharmaceuticals, LLC are 21 CFR 211.192 (Production record review), 4 times; 21 CFR 211.198 (Complaint files), 4 times; 21 CFR 211.22 (Responsibilities of quality control unit), 3 times.