Overview
- 6 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-06-27.
At a glance
Inspections
6
Form 483s
4
EIRs
5
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Jun 2024 – 27 Jun 2024 | Human Drugs | 483 | On file |
| 21 Aug 2023 – 25 Aug 2023 | Human Drugs | Clean | |
| 24 Oct 2022 – 3 Nov 2022 | Human Drugs | 483 | View 483 → |
| 20 Oct 2021 – 9 Nov 2021 | Human Drugs | 483 | View 483 → |
| 11 Aug 2020 – 18 Aug 2020 | Human Drugs | Clean | |
| 9 May 2018 – 17 May 2018 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
3 Nov 2022
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Mindy M Chou, Robin P Mathew, Victoria Spivak
3 Nov 2022
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Mindy M Chou, Robin P Mathew, Victoria Spivak
3 Nov 2022
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Mindy M Chou, Robin P Mathew, Victoria Spivak
3 Nov 2022
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Mindy M Chou, Robin P Mathew, Victoria Spivak
3 Nov 2022
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Mindy M Chou, Robin P Mathew, Victoria Spivak
Investigators
FDA investigators tied to this site in the record.
Robin P Mathew3 insp.
Adetutu M Gidado2 insp.
Unnee Ranjan2 insp.
Pushpa S Jayasekara1 insp.
Mindy M Chou1 insp.
Victoria Spivak1 insp.
James M Mason1 insp.
Nicholas A Violand1 insp.
Michael R Klapal1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.65(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Advanced Accelerator Applications USA, Inc.'s 4 Form 483s
Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat