Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-12-19.
At a glance
Inspections
6
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Dec 2025 – 19 Dec 2025 | Human Drugs | 483 | On file |
| 31 Jul 2024 | Foods & Cosmetics | Clean | |
| 11 Apr 2022 – 14 Apr 2022 | Human Drugs | 483 | View 483 → |
| 27 Sep 2016 – 29 Sep 2016 | Human Drugs | 483 | On file |
| 25 Sep 2012 | Not recorded | Clean | |
| 24 Feb 2010 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Apr 2022
21 CFR 211.142(b)
Storage under appropriate conditions
Cited by Jared P Stevens, Harshal J Desai, Angelica M Hernandez
14 Apr 2022
21 CFR 211.63
Equipment Design, Size and Location
Cited by Jared P Stevens, Harshal J Desai, Angelica M Hernandez
14 Apr 2022
21 CFR 211.68(b)
Computer control of master formula records
Cited by Jared P Stevens, Harshal J Desai, Angelica M Hernandez
Investigators
FDA investigators tied to this site in the record.
Mercedes N Overton1 insp.
Mokhless A Ghaly1 insp.
Jared P Stevens1 insp.
Harshal J Desai1 insp.
Angelica M Hernandez1 insp.
Christopher S Keating1 insp.
Eileen J Bannerman1 insp.
Tracy R Ball1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind FillTech USA, LLC's 3 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