Overview
- 10 FDA inspections are on record.
- 10 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-14.
At a glance
Inspections
10
Form 483s
10
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 May 2026 – 14 May 2026 | Biologics | 483 | View 483 → |
| 27 Nov 2023 – 5 Dec 2023 | Biologics | 483 | View 483 → |
| 21 Feb 2019 – 27 Feb 2019 | Biologics | 483 | On file |
| 14 Aug 2017 – 17 Aug 2017 | Medical Devices & Rad Health | 483 | On file |
| 10 Jan 2017 – 13 Jan 2017 | Biologics | 483 | On file |
| 21 Jan 2015 – 27 Jan 2015 | Medical Devices & Rad Health | 483 | On file |
| 4 Feb 2013 – 8 Feb 2013 | Medical Devices & Rad Health | 483 | On file |
| 3 Aug 2012 | Not recorded | 483 | On file |
| 12 Jan 2012 | Not recorded | 483 | On file |
| 6 May 2011 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
14 May 2026
ISO 13485:2016 Clause 7.1
Records of risk management activities in product realization not maintained
Cited by Marla A Cassidy, David E Lowe
5 Dec 2023
21 CFR 820.150
Lack of or inadequate procedures for storage.
Cited by Gene D Arcy, Priscilla M Pastrana, Edward A Brunt
5 Dec 2023
21 CFR 820.184
DHR - not or inadequately maintained
Cited by Gene D Arcy, Priscilla M Pastrana, Edward A Brunt
5 Dec 2023
21 CFR 820.60
Identification procedures, Lack of or inadequate procedures
Cited by Gene D Arcy, Priscilla M Pastrana, Edward A Brunt
Investigators
FDA investigators tied to this site in the record.
Burnell M Henry2 insp.
Martha T Olone2 insp.
Marla A Cassidy1 insp.
David E Lowe1 insp.
Gene D Arcy1 insp.
Priscilla M Pastrana1 insp.
Edward A Brunt1 insp.
Jacqueline M Diaz Albert1 insp.
MDSAP WilliamsA1 insp.
Prabhu P Raju1 insp.
Christian Lynch1 insp.
Lori P Peters1 insp.
Deborah M Trout1 insp.
Esra Toussaint1 insp.
Jennifer L Schmidt1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.150 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.60 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.1 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Avioq, Inc.'s 10 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