Overview
- 29 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-09-23.
At a glance
Inspections
29
Form 483s
9
EIRs
5
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Sep 2025 – 23 Sep 2025 | Human Drugs | 483 | On file |
| 26 Mar 2024 – 27 Mar 2024 | Foods & Cosmetics | Clean | |
| 27 Jun 2023 – 30 Jun 2023 | Foods & Cosmetics | Clean | |
| 3 Oct 2022 – 13 Oct 2022 | Foods & Cosmetics | Clean | |
| 28 Feb 2022 – 3 Mar 2022 | Human Drugs | 483 | On file |
| 24 May 2021 – 28 May 2021 | Human Drugs | 483 | On file |
| 17 Jun 2019 – 25 Jun 2019 | Biologics | 483 | On file |
| 21 May 2019 – 23 May 2019 | Foods & Cosmetics | Clean | |
| 25 Sep 2018 – 26 Sep 2018 | Foods & Cosmetics | Clean | |
| 13 Jun 2018 – 3 Jul 2018 | Human Drugs | 483 | On file |
| 26 Oct 2015 – 16 Nov 2015 | Human Drugs | Clean | |
| 23 Jul 2014 – 22 Aug 2014 | Medical Devices & Rad Health | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
3 Jul 2018
21 CFR 820.86
Acceptance status
Cited by Brittani N Franklin, Christopher D Leach
3 Jul 2018
21 CFR 820.86
Acceptance status
Cited by Brittani N Franklin, Christopher D Leach
3 Jul 2018
21 CFR 820.86
Acceptance status
Cited by Brittani N Franklin, Christopher D Leach
22 Aug 2014
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Christopher D Leach
22 Aug 2014
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Christopher D Leach
Investigators
FDA investigators tied to this site in the record.
Christopher D Leach5 insp.
Brian D Nicholson3 insp.
Martin R Vowell2 insp.
Jason F Chancey2 insp.
Adetutu M Gidado1 insp.
Pablo Alcantara1 insp.
Sarah Nwandiuko1 insp.
Roshni J Patel1 insp.
Shana L Williams1 insp.
Michele L Glendenning1 insp.
Anders W Evenson1 insp.
Wendy G Tan1 insp.
Milva E Melendez Perales1 insp.
Wayne E Seifert1 insp.
Dariusz Galezowski1 insp.
Daniel B Arrecis1 insp.
Latoya A Griffith1 insp.
Brittani N Franklin1 insp.
Frank Wackes1 insp.
Jonathan G Swoboda1 insp.
Jennifer C Adams1 insp.
Russell K Riley1 insp.
Susan W Ciani1 insp.
Christina A Miller1 insp.
Carrie-Ann Plucinski1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.86 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.94(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Woodstock Sterile Solutions Inc's 9 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