Overview
- 25 FDA inspections are on record.
- 11 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-21.
At a glance
Inspections
25
Form 483s
11
EIRs
5
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Oct 2025 – 21 Nov 2025 | Human Drugs | 483 | View 483 → |
| 5 Aug 2024 – 6 Aug 2024 | Biologics | Clean | |
| 6 Dec 2023 – 15 Dec 2023 | Human Drugs | 483 | View 483 → |
| 11 Oct 2023 – 13 Oct 2023 | Medical Devices & Rad Health | Clean | |
| 9 Aug 2021 – 17 Aug 2021 | Human Drugs | 483 | On file |
| 22 Jun 2020 – 23 Jul 2020 | Human Drugs | 483 | View 483 → |
| 4 Jun 2018 – 29 Jun 2018 | Human Drugs | 483 | View 483 → |
| 18 Apr 2016 – 11 May 2016 | Human Drugs | WL | View 483 → |
| 18 Feb 2015 – 3 Mar 2015 | Human Drugs | 483 | View 483 → |
| 22 Jan 2014 – 13 Feb 2014 | Human Drugs | 483 | View 483 → |
| 8 Oct 2013 – 13 Nov 2013 | Human Drugs | Clean | |
| 23 Apr 2013 – 17 May 2013 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Nov 2025
21 CFR 211.160(b)(3)
Acceptance of drug products
Cited by Joey V Quitania, Roger F Zabinski, Walden H Lee, Lillian S Wu, Andrew Le, Homero W Aguilar
21 Nov 2025
21 CFR 211.165(f)
Failing drug products not rejected
Cited by Joey V Quitania, Roger F Zabinski, Walden H Lee, Lillian S Wu, Andrew Le, Homero W Aguilar
21 Nov 2025
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Joey V Quitania, Roger F Zabinski, Walden H Lee, Lillian S Wu, Andrew Le, Homero W Aguilar
21 Nov 2025
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Joey V Quitania, Roger F Zabinski, Walden H Lee, Lillian S Wu, Andrew Le, Homero W Aguilar
21 Nov 2025
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Joey V Quitania, Roger F Zabinski, Walden H Lee, Lillian S Wu, Andrew Le, Homero W Aguilar
Investigators
FDA investigators tied to this site in the record.
Joey V Quitania3 insp.
Walden H Lee3 insp.
Jennifer M Gogley3 insp.
Binh T Nguyen3 insp.
Uttaniti Limchumroon2 insp.
Caryn M Mcnab2 insp.
Roger F Zabinski1 insp.
Lillian S Wu1 insp.
Andrew Le1 insp.
Homero W Aguilar1 insp.
Zachary A Bogorad1 insp.
Maurine Fadlalla1 insp.
Amir Alavi1 insp.
Dogbeda F Mackenzie1 insp.
Cecilia H Kieu1 insp.
Luis P Torres1 insp.
Alexandria L Capuano1 insp.
Christopher R Czajka1 insp.
Truong X Nguyen1 insp.
Sidonie J Takougang1 insp.
Carrie A Hughes1 insp.
Amanda L Fyles1 insp.
Evelyn Wong1 insp.
Anastasia M Shields1 insp.
Carla J Lundi1 insp.
Chelsea N Sealey1 insp.
Brian J Ryan1 insp.
Sundy Ven1 insp.
Rebecca Rodriguez1 insp.
Nabeela J Chaudhry1 insp.
Sean P Desbrow1 insp.
Gene D Arcy1 insp.
Linda Thai1 insp.
Diane C Van Leeuwen1 insp.
John A Gonzalez1 insp.
Nelly N Tran1 insp.
Thao T Kwan1 insp.
Kham Phommachanh1 insp.
Virgilio F Pacio1 insp.
Kirtida Patel1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 10x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(c)(5) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(4) | 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(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.65(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind B. Braun US Pharmaceutical Manufacturing, LLC's 11 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