Overview
- 13 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-13.
At a glance
Inspections
13
Form 483s
5
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Feb 2026 – 13 Feb 2026 | Human Drugs | 483 | View 483 → |
| 3 Jun 2025 | Medical Devices & Rad Health | Clean | |
| 10 May 2023 | Medical Devices & Rad Health | Clean | |
| 15 Aug 2022 – 19 Aug 2022 | Human Drugs | 483 | View 483 → |
| 15 Aug 2017 – 18 Aug 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Oct 2015 – 19 Oct 2015 | Human Drugs | Clean | |
| 7 Jan 2013 | Not recorded | 483 | View 483 → |
| 4 Nov 2011 | Not recorded | 483 | View 483 → |
| 7 Apr 2011 | Not recorded | Clean | |
| 4 Feb 2009 | Not recorded | Clean | |
| 7 Aug 2008 | Not recorded | Clean | |
| 7 Sep 2006 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
19 Aug 2022
21 CFR 211.56(a)
Sanitation--buildings not clean, free of infestation
Cited by Joseph A Piechocki
Investigators
FDA investigators tied to this site in the record.
Marie A Fadden2 insp.
Beatrix D Hippe1 insp.
Tyler R Courtney1 insp.
Benjamin W Anderson1 insp.
Joseph A Piechocki1 insp.
Jennifer S Ness1 insp.
Gregory A Berg1 insp.
Courtney R Tiegs1 insp.
Ivan E Reyes1 insp.
April L Young1 insp.
Yehualashe A Gessesse1 insp.
Janis R Armendariz1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Birchwood Laboratories, LLC's 5 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