Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-01-25.
At a glance
Inspections
4
Form 483s
2
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Jan 2019 – 25 Jan 2019 | Human Drugs | 483 | View 483 → |
| 25 Aug 2015 – 1 Sep 2015 | Human Drugs | 483 | View 483 → |
| 25 Apr 2013 – 30 Apr 2013 | Human Drugs | Clean | |
| 9 Jan 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Jan 2019
21 CFR 211.165(f)
Failing drug products not rejected
Cited by Anthony J Ladner, Victoria A Wagoner
25 Jan 2019
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Anthony J Ladner, Victoria A Wagoner
1 Sep 2015
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Gregory A Berg, Patrick B Cummings, April L Young
1 Sep 2015
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Gregory A Berg, Patrick B Cummings, April L Young
1 Sep 2015
21 CFR 211.180(e)(1)
Review of representative number of batches
Cited by Gregory A Berg, Patrick B Cummings, April L Young
Investigators
FDA investigators tied to this site in the record.
Anthony J Ladner1 insp.
Victoria A Wagoner1 insp.
Gregory A Berg1 insp.
Patrick B Cummings1 insp.
April L Young1 insp.
Ivan E Reyes1 insp.
Janis R Armendariz1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(f) | 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 |
Full site report
Get the verbatim findings behind 3M Company's 2 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