Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-06-24.
At a glance
Inspections
4
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Jun 2026 – 24 Jun 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 12 Aug 2013 – 13 Aug 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 2 May 2008 | Not recorded | 483 | On file |
| 17 Nov 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Jun 2026
ISO 13485:2016 Clause 7.3.10
Design and development files not maintained
Cited by Nadia R Barreda
24 Jun 2026
ISO 13485:2016 Clause 7.5.6
Procedures for validation of processes not documented
Cited by Nadia R Barreda
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.3.10 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.5.6 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Boehringer Laboratories, Inc.'s 3 Form 483s
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