Overview
- 11 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-05-16.
At a glance
Inspections
11
Form 483s
5
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 May 2024 – 16 May 2024 | Human Drugs | 483 | On file |
| 11 Apr 2023 – 13 Apr 2023 | Human Drugs | Clean | |
| 25 Oct 2022 – 4 Nov 2022 | Human Drugs | 483 | View 483 → |
| 16 Aug 2018 – 24 Aug 2018 | Medical Devices & Rad Health | 483 | On file |
| 27 Mar 2017 – 4 Apr 2017 | Human Drugs | 483 | On file |
| 19 May 2014 – 28 May 2014 | Human Drugs | Clean | |
| 7 Aug 2012 | Not recorded | Clean | |
| 25 Feb 2010 | Not recorded | 483 | View 483 → |
| 10 Sep 2008 | Not recorded | Clean | |
| 11 Apr 2008 | Not recorded | Clean | |
| 5 Jun 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
4 Nov 2022
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Jeffrey P Raimondi, Christopher R Czajka
25 Feb 2010
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Peter E Baker, Thomas J Arista, William V Millar
25 Feb 2010
21 CFR 211.46(b)
Equipment for Environmental Control
Cited by Peter E Baker, Thomas J Arista, William V Millar
25 Feb 2010
21 CFR 211.46(c)
Exhaust systems inadequate to control air contamination
Cited by Peter E Baker, Thomas J Arista, William V Millar
25 Feb 2010
21 CFR 211.56(c)
Written procedures lacking for use of pesticides etc.
Cited by Peter E Baker, Thomas J Arista, William V Millar
Investigators
FDA investigators tied to this site in the record.
Peter E Baker2 insp.
Lindsey J Brown1 insp.
Yun Wu1 insp.
Abigail V Marella1 insp.
Nicholas L Hunt1 insp.
Dogbeda F Mackenzie1 insp.
Sara H Gabel1 insp.
Jeffrey P Raimondi1 insp.
Christopher R Czajka1 insp.
Marcus F Yambot1 insp.
Anita Narula1 insp.
Diane L Raccasi1 insp.
Kristin M Abaonza1 insp.
Monica M Commerford1 insp.
Maria I Cruz-Fisher1 insp.
Ephrem T Hunde1 insp.
Lance M De Souza1 insp.
Rebecca Rodriguez1 insp.
Thomas J Arista1 insp.
William V Millar1 insp.
Jeffrey M Watson1 insp.
Douglas A Campbell1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | 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(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Boehringer Ingelheim Fremont, Inc.'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