Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-06-19.
At a glance
Inspections
5
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Jun 2024 – 19 Jun 2024 | Human Drugs | Clean | |
| 8 Jul 2019 – 10 Jul 2019 | Human Drugs | Clean | |
| 19 Mar 2018 – 23 Mar 2018 | Human Drugs | 483 | On file |
| 4 Apr 2016 – 8 Apr 2016 | Human Drugs | 483 | View 483 → |
| 9 Dec 2013 – 13 Dec 2013 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Apr 2016
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Samantha J Bradley, Charanjeet Jassal
8 Apr 2016
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Samantha J Bradley, Charanjeet Jassal
8 Apr 2016
21 CFR 211.188(b)(5)
In-process and laboratory control results
Cited by Samantha J Bradley, Charanjeet Jassal
8 Apr 2016
21 CFR 211.63
Equipment Design, Size and Location
Cited by Samantha J Bradley, Charanjeet Jassal
8 Apr 2016
21 CFR 211.142(b)
Storage under appropriate conditions
Cited by Samantha J Bradley, Charanjeet Jassal
Investigators
FDA investigators tied to this site in the record.
MRA M BarbosaR1 insp.
MRA McCulloughJ1 insp.
Kenneth E Felkley1 insp.
Samantha J Bradley1 insp.
Charanjeet Jassal1 insp.
Michael R Goga1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 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(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Bayer Bitterfeld GmbH's 3 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