Advanced Accelerator Applications USA, Inc.
FDA inspection history in Millburn, New Jersey, 2021 to 2024
- 3
- Form 483s
Every document, by year
- Form 483
2021: one Form 483; 2022: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021–24Three Form 483s, at Millburn, New Jersey.
- 2021The longest 483 on file: 7 observations over 8 pages at Millburn, New Jersey.
Cited most
Across all Advanced Accelerator Applications USA observations on file
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.192Production record review2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures2
- 21 CFR 211.100(a)Written procedures; deviations1
The complete Advanced Accelerator Applications USA file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Millburn, New Jersey
Three Form 483s · 2021 to 2024 · 15 observations
Latest: Form 483, Jun 27, 2024 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-06-27 | 483 Form 483 | Millburn, New Jersey | 3 | $99 |
| 2022-11-03 | 483 Form 483 | Millburn, New Jersey | 5 | $99 |
| 2021-11-09 | 483 Form 483 | Millburn, New Jersey | 7 | $99 |
Investigators on these documents
FEI number 3012484129 · most recent document Jun 27, 2024
About Advanced Accelerator Applications USA, Inc.
How many FDA Form 483s has Advanced Accelerator Applications USA, Inc. received?
FDA Intel has 3 Form 483s on file for Advanced Accelerator Applications USA, Inc.; the most recent is dated Jun 27, 2024.
When was Advanced Accelerator Applications USA, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Advanced Accelerator Applications USA, Inc. is a Form 483 dated Jun 27, 2024, for the site in Millburn, New Jersey.
What did FDA cite at Advanced Accelerator Applications USA, Inc.?
The regulations cited most in the observations on file for Advanced Accelerator Applications USA, Inc. are 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.22 (Responsibilities of quality control unit), 2 times.