Overview
- 9 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-09-01.
At a glance
Inspections
9
Form 483s
7
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Aug 2023 – 1 Sep 2023 | Human Drugs | 483 | View 483 → |
| 15 Jul 2019 – 26 Jul 2019 | Human Drugs | 483 | View 483 → |
| 9 Apr 2018 – 27 Apr 2018 | Human Drugs | 483 | View 483 → |
| 31 Mar 2014 – 11 Apr 2014 | Human Drugs | 483 | View 483 → |
| 28 Sep 2011 | Not recorded | 483 | View 483 → |
| 4 Dec 2009 | Not recorded | WL | View 483 → |
| 18 Jul 2008 | Not recorded | 483 | On file |
| 19 Aug 2005 | Not recorded | Clean | |
| 3 Oct 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
1 Sep 2023
21 CFR 211.122(d)
Label storage access limited to authorized personnel
Cited by Steven A Brettler
26 Jul 2019
21 CFR 211.160(b)(3)
Acceptance of drug products
Cited by Jennifer Lalama, Richard A Lyght, Youmin Wang, Haley H Seymour, Dipti Kalra
26 Jul 2019
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Jennifer Lalama, Richard A Lyght, Youmin Wang, Haley H Seymour, Dipti Kalra
26 Jul 2019
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Jennifer Lalama, Richard A Lyght, Youmin Wang, Haley H Seymour, Dipti Kalra
Investigators
FDA investigators tied to this site in the record.
Ileana Barreto-Pettit3 insp.
Jennifer Lalama2 insp.
Steven A Brettler1 insp.
Richard A Lyght1 insp.
Youmin Wang1 insp.
Haley H Seymour1 insp.
Dipti Kalra1 insp.
Rozelle G Smith1 insp.
Jessica L Pressley1 insp.
Dawn M Mccabe1 insp.
Salvatore N Randazzo1 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 | 7x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(12) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.52 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Aveva Drug Delivery Systems Inc.'s 7 Form 483s
Source PDFs, verbatim observations, 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