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 | On file |
| 7 Apr 2021 – 14 Apr 2021 | Human Drugs | 483 | On file |
| 11 Oct 2016 – 24 Oct 2016 | Human Drugs | 483 | On file |
| 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
Cited by Paranthaman SenthamaraiKannan, Olumide A Akinyemi
13 Nov 2024
21 CFR 211.182
Personnel dating/signing equipment log
Cited by Paranthaman SenthamaraiKannan, Olumide A Akinyemi
13 Nov 2024
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Paranthaman SenthamaraiKannan, Olumide A Akinyemi
13 Nov 2024
21 CFR 211.56(a)
Sanitation--buildings not clean, free of infestation
Cited by Paranthaman SenthamaraiKannan, Olumide A Akinyemi
13 Nov 2024
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Paranthaman SenthamaraiKannan, Olumide A Akinyemi
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