Overview
- 7 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-11-13.
At a glance
Inspections
7
Form 483s
4
EIRs
5
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Nov 2024 – 13 Nov 2024 | Human Drugs | 483 | View 483 → |
| 7 Apr 2021 – 14 Apr 2021 | Human Drugs | 483 | View 483 → |
| 11 Oct 2016 – 24 Oct 2016 | Human Drugs | 483 | View 483 → |
| 13 Jul 2015 – 17 Jul 2015 | Human Drugs | 483 | On file |
| 17 Aug 2012 | Not recorded | Clean | |
| 10 Dec 2010 | Not recorded | Clean | |
| 15 Apr 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Nov 2024
21 CFR 211.160(b)
Scientifically sound laboratory controls
13 Nov 2024
21 CFR 211.182
Personnel dating/signing equipment log
13 Nov 2024
21 CFR 211.192
Investigations of discrepancies, failures
13 Nov 2024
21 CFR 211.56(a)
Sanitation--buildings not clean, free of infestation
13 Nov 2024
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Investigators
FDA investigators tied to this site in the record.
Michael P Sheehan2 insp.
Nicholas L Paulin2 insp.
Olumide A Akinyemi1 insp.
Jon P Antoniou1 insp.
Logan T Williams1 insp.
Kenneth E Felkley1 insp.
Kathleen D Culver1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Avantor Performance Materials, LLC's 4 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