Overview
- 8 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-22.
At a glance
Inspections
8
Form 483s
2
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 May 2026 – 22 May 2026 | Human Drugs | Clean | |
| 31 May 2023 – 7 Jun 2023 | Human Drugs | Clean | |
| 25 Jan 2023 – 1 Feb 2023 | Foods & Cosmetics | Clean | |
| 7 Aug 2017 – 11 Aug 2017 | Human Drugs | 483 | View 483 → |
| 9 Oct 2013 – 18 Oct 2013 | Human Drugs | 483 | View 483 → |
| 21 Jul 2011 | Not recorded | Clean | |
| 22 Jun 2009 | Not recorded | Clean | |
| 25 Apr 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Aug 2017
21 CFR 211.22(a)
Authority lacking to review records, investigate errors
Cited by Deyaa Shaheen, Sena G Dissmeyer, Jacquelyn Gess
11 Aug 2017
21 CFR 211.22(a)
Authority lacking to review records, investigate errors
Cited by Deyaa Shaheen, Sena G Dissmeyer, Jacquelyn Gess
11 Aug 2017
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Deyaa Shaheen, Sena G Dissmeyer, Jacquelyn Gess
11 Aug 2017
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Deyaa Shaheen, Sena G Dissmeyer, Jacquelyn Gess
11 Aug 2017
21 CFR 211.68(b)
Computer control of master formula records
Cited by Deyaa Shaheen, Sena G Dissmeyer, Jacquelyn Gess
Investigators
FDA investigators tied to this site in the record.
James M Mason3 insp.
Claude Noel Y Zanetsie1 insp.
Amy N Chen1 insp.
Maureen A Wentzel1 insp.
Deyaa Shaheen1 insp.
Sena G Dissmeyer1 insp.
Jacquelyn Gess1 insp.
William C Brenneman1 insp.
Caryn M Mcnab1 insp.
Anita R Michael1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Bayer HealthCare LLC'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