Overview
- 16 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-07-17.
At a glance
Inspections
16
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Jul 2025 – 17 Jul 2025 | Human Drugs | 483 | View 483 → |
| 28 Jan 2019 – 30 Jan 2019 | Human Drugs | Clean | |
| 7 Aug 2017 – 11 Aug 2017 | Human Drugs | Clean | |
| 27 Jan 2015 – 29 Jan 2015 | Human Drugs | Clean | |
| 12 Sep 2013 – 18 Sep 2013 | Human Drugs | Clean | |
| 26 Sep 2012 | Not recorded | Clean | |
| 2 Jul 2012 | Not recorded | 483 | View 483 → |
| 6 Jun 2012 | Not recorded | 483 | View 483 → |
| 14 Sep 2010 | Not recorded | Clean | |
| 21 Sep 2009 | Not recorded | Clean | |
| 15 Oct 2007 | Not recorded | Clean | |
| 12 Apr 2007 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Jul 2025
21 CFR 211.188(b)
Batch production and Batch Control Record Requirements
Cited by Daveta L Bailey, J'Maica J Hunter
17 Jul 2025
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Daveta L Bailey, J'Maica J Hunter
17 Jul 2025
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Daveta L Bailey, J'Maica J Hunter
Investigators
FDA investigators tied to this site in the record.
Viviana Matta3 insp.
Daveta L Bailey1 insp.
J'Maica J Hunter1 insp.
Susan O Oladeji1 insp.
Reba A Gates1 insp.
Seneca D Toms1 insp.
Metitia G Sanders1 insp.
Metitia M Gramby1 insp.
Eileen J Bannerman1 insp.
Jawaid Hamid1 insp.
Barbara M Frazier1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.353 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.365 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind ThermoFisher Scientific's 3 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