Overview
- 18 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-12-18.
At a glance
Inspections
18
Form 483s
9
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Dec 2023 – 18 Dec 2023 | Animal Drugs & Feeds | 483 | View 483 → |
| 23 Aug 2021 – 14 Sep 2021 | Animal Drugs & Feeds | 483 | View 483 → |
| 1 May 2019 – 17 May 2019 | Animal Drugs & Feeds | 483 | View 483 → |
| 4 Dec 2017 – 11 Jan 2018 | Animal Drugs & Feeds | 483 | View 483 → |
| 17 Jan 2017 – 1 Feb 2017 | Animal Drugs & Feeds | WL | View 483 → |
| 8 Feb 2016 – 17 Feb 2016 | Animal Drugs & Feeds | 483 | View 483 → |
| 15 Mar 2013 – 27 Mar 2013 | Human Drugs | Clean | |
| 21 Jan 2011 | Not recorded | 483 | View 483 → |
| 6 Jan 2010 | Not recorded | 483 | View 483 → |
| 26 Aug 2009 | Not recorded | Clean | |
| 14 Jul 2008 | Not recorded | Clean | |
| 13 Jun 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Dec 2023
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Christopher R Czajka, Walden H Lee
18 Dec 2023
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Christopher R Czajka, Walden H Lee
18 Dec 2023
21 CFR 211.101(b)
Measured components for manufacturing
Cited by Christopher R Czajka, Walden H Lee
14 Sep 2021
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Uttaniti Limchumroon, Walden H Lee, Joel D Hustedt, Sandra A Boyd
Investigators
FDA investigators tied to this site in the record.
Walden H Lee3 insp.
Nicholas L Hunt2 insp.
Marcus F Yambot2 insp.
Carla J Lundi2 insp.
Christopher R Czajka1 insp.
Uttaniti Limchumroon1 insp.
Joel D Hustedt1 insp.
Sandra A Boyd1 insp.
Zachary A Bogorad1 insp.
Jolanna A Norton1 insp.
Carrie A Hughes1 insp.
Robert D Tollefsen1 insp.
Mai X Huynh1 insp.
Anastasia M Shields1 insp.
Julia Ventura1 insp.
John A Gonzalez1 insp.
Kham Phommachanh1 insp.
Truong X Nguyen1 insp.
Binh T Nguyen1 insp.
Cntrctmntr2 Lee1 insp.
Caryn M Mcnab1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 8x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 8x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 225.58(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 514.80(b)(2)(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.101(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.44 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.65(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(3) | 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)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.87 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 514.80(b)(2)(ii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Bimeda Pomona Inc.'s 9 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