Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-01-31.
At a glance
Inspections
4
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Jan 2025 – 31 Jan 2025 | Human Drugs | 483 | View 483 → |
| 8 Nov 2022 – 22 Nov 2022 | Human Drugs | 483 | View 483 → |
| 18 Oct 2021 – 5 Nov 2021 | Human Drugs | 483 | View 483 → |
| 19 Oct 2020 – 30 Oct 2020 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
31 Jan 2025
21 CFR 211.110(b)
In-process conformity - examination, sample testing
Cited by Santos E Camara
31 Jan 2025
21 CFR 211.42(b)
Adequate space lacking to prevent mix-ups and contamination
Cited by Santos E Camara
22 Nov 2022
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Jose F Velez, Michael T Cyrus, Michelle K Cockrell
Investigators
FDA investigators tied to this site in the record.
Santos E Camara1 insp.
Jose F Velez1 insp.
Michael T Cyrus1 insp.
Michelle K Cockrell1 insp.
Saundrea A Munroe1 insp.
Mary A Millner1 insp.
Nakesha J Jackson1 insp.
Jessica L Pressley1 insp.
Ileana Barreto-Pettit1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.115(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind B. Braun US Pharmaceutical Manufacturing LLC's 4 Form 483s
Source PDFs 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