Overview
- 34 FDA inspections are on record.
- 17 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-12-11.
At a glance
Inspections
34
Form 483s
17
EIRs
8
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 1 Dec 2025 – 11 Dec 2025 | Biologics | 483 | View 483 → |
| 16 Sep 2024 – 24 Sep 2024 | Human Drugs | 483 | On file |
| 22 Jul 2024 – 26 Jul 2024 | Biologics | 483 | On file |
| 14 Feb 2024 – 20 Feb 2024 | Human Drugs | 483 | On file |
| 13 Feb 2023 – 17 Feb 2023 | Human Drugs | Clean | |
| 2 Nov 2021 – 10 Nov 2021 | Biologics | 483 | On file |
| 16 May 2018 – 23 May 2018 | Biologics | 483 | On file |
| 10 Jul 2017 – 17 Jul 2017 | Human Drugs | 483 | On file |
| 4 May 2016 – 12 May 2016 | Biologics | 483 | On file |
| 18 May 2015 | Human Drugs | Clean | |
| 20 Oct 2014 – 24 Oct 2014 | Human Drugs | 483 | On file |
| 29 Apr 2014 – 2 May 2014 | Human Drugs | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Dec 2025
21 CFR 211.192
Quality control unit review of records
Cited by Priscilla M Pastrana, Lizaida Perez
11 Dec 2025
21 CFR 211.56(a)
Sanitation--buildings not clean, free of infestation
Cited by Priscilla M Pastrana, Lizaida Perez
17 Jul 2017
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Robert M Barbosa
10 May 2013
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Rebecca E Dombrowski, Jeffrey D Meng, Andrew J Idzior, Sarah M Meng, Cheng H Yen
10 May 2013
21 CFR 211.80(a)
Procedures To Be in Writing
Cited by Rebecca E Dombrowski, Jeffrey D Meng, Andrew J Idzior, Sarah M Meng, Cheng H Yen
Investigators
FDA investigators tied to this site in the record.
Robert M Barbosa7 insp.
Larry K Austin7 insp.
Michele L Forster2 insp.
Jeffrey D Meng2 insp.
Priscilla M Pastrana1 insp.
Lizaida Perez1 insp.
Wayne E Seifert1 insp.
Muna Algharibeh1 insp.
Mia J Chang1 insp.
Xiuju Lu1 insp.
Laurimer Kuilan-Torres1 insp.
Ruo H Xu1 insp.
Yiwei Li1 insp.
Michele L Glendenning1 insp.
Peng Zhou1 insp.
Enrico-Jose T Mangahis1 insp.
Brentley S Collins1 insp.
Scott T Ballard1 insp.
Burnell M Henry1 insp.
Simone E Pitts1 insp.
Susan M Jackson1 insp.
Rebecca E Dombrowski1 insp.
Andrew J Idzior1 insp.
Sarah M Meng1 insp.
Cheng H Yen1 insp.
Meisha R Sampson1 insp.
Constantin Y Philopoulos1 insp.
Sarah M Napier1 insp.
Ifueko Osemwota1 insp.
David A Paterson1 insp.
Helen B Ricalde1 insp.
Emily J Orban1 insp.
Patsy J Domingo1 insp.
Sarah B Tanksley1 insp.
Jennifer L Schmidt1 insp.
Rose M Ashley1 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 | 4x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(3) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Simtra US LLC's 17 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