Overview
- 12 FDA inspections are on record.
- 10 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-12-15.
At a glance
Inspections
12
Form 483s
10
EIRs
6
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 30 Nov 2023 – 15 Dec 2023 | Human Drugs | 483 | View 483 → |
| 5 Dec 2022 – 14 Dec 2022 | Human Drugs | 483 | View 483 → |
| 22 Jul 2019 – 1 Aug 2019 | Human Drugs | 483 | View 483 → |
| 3 Aug 2016 – 15 Aug 2016 | Human Drugs | 483 | On file |
| 21 Jul 2015 – 30 Jul 2015 | Human Drugs | 483 | View 483 → |
| 23 Oct 2013 – 1 Nov 2013 | Human Drugs | 483 | View 483 → |
| 8 May 2013 – 21 May 2013 | Human Drugs | 483 | View 483 → |
| 8 Mar 2012 | Not recorded | 483 | View 483 → |
| 10 Jun 2010 | Not recorded | 483 | View 483 → |
| 17 Jun 2009 | Not recorded | 483 | View 483 → |
| 28 Feb 2001 | Not recorded | Clean | |
| 27 Feb 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Dec 2023
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Jill J Tillman, Megan T Ziegler
15 Dec 2023
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Jill J Tillman, Megan T Ziegler
14 Dec 2022
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Lisa L Flores, Gretchen L Trendel, Michael C Zubelewicz
14 Dec 2022
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Lisa L Flores, Gretchen L Trendel, Michael C Zubelewicz
14 Dec 2022
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Lisa L Flores, Gretchen L Trendel, Michael C Zubelewicz
Investigators
FDA investigators tied to this site in the record.
Michele L Obert3 insp.
Tara L Breckenridge3 insp.
Victoria A Wagoner2 insp.
Jill J Tillman1 insp.
Megan T Ziegler1 insp.
Lisa L Flores1 insp.
Gretchen L Trendel1 insp.
Michael C Zubelewicz1 insp.
Marcus F Yambot1 insp.
Alan L Truong1 insp.
Veronica Fuentes1 insp.
Rita K Kabaso1 insp.
Tara L Greene1 insp.
Kellia N Hicks1 insp.
Brittany D Terhar1 insp.
Steven D Kehoe1 insp.
Thomas J Arista1 insp.
Joseph R Lambert1 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 | 11x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 9x |
| 21 CFR 211.42(c)(10)(i) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.87 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.130(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.184(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(3) | 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 211.25(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(vi) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Argenta US Manufacturing LLC's 10 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