Overview
- 9 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-09-07.
At a glance
Inspections
9
Form 483s
6
EIRs
3
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 Sep 2023 – 7 Sep 2023 | Human Drugs | Clean | |
| 20 Jul 2020 – 27 Jul 2020 | Human Drugs | 483 | View 483 → |
| 11 Mar 2019 – 22 Mar 2019 | Human Drugs | 483 | View 483 → |
| 12 Jan 2017 – 20 Jan 2017 | Human Drugs | WL | On file |
| 30 May 2016 – 3 Jun 2016 | Human Drugs | Clean | |
| 10 Nov 2014 – 14 Nov 2014 | Human Drugs | 483 | On file |
| 9 Jul 2012 | Not recorded | 483 | View 483 → |
| 23 Feb 2010 | Not recorded | 483 | View 483 → |
| 15 Oct 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Jul 2020
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Michael A Charles, Wayne D Mcgrath
27 Jul 2020
21 CFR 211.130(a)
Prevention of cross contamination, mix-ups
Cited by Michael A Charles, Wayne D Mcgrath
27 Jul 2020
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Michael A Charles, Wayne D Mcgrath
27 Jul 2020
21 CFR 211.192
Written record of investigation incomplete
Cited by Michael A Charles, Wayne D Mcgrath
27 Jul 2020
21 CFR 211.67(b)
Written procedures fail to include
Cited by Michael A Charles, Wayne D Mcgrath
Investigators
FDA investigators tied to this site in the record.
MRA M BarbosaR1 insp.
Michael A Charles1 insp.
Wayne D Mcgrath1 insp.
Noreen Muniz1 insp.
Alan P Kurtzberg1 insp.
Justin A Boyd1 insp.
Latorie S Jones1 insp.
Alberto A Viciedo1 insp.
Torrance J Slayton1 insp.
Matthew B Casale1 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 | 3x |
| 21 CFR 211.122(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.105(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Bayer AG's 6 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