Overview
- 19 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-06-17.
At a glance
Inspections
19
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Jun 2025 | Medical Devices & Rad Health | Clean | |
| 14 Feb 2024 | Medical Devices & Rad Health | Clean | |
| 13 Apr 2023 | Medical Devices & Rad Health | Clean | |
| 2 Jun 2022 | Medical Devices & Rad Health | Clean | |
| 13 Aug 2019 | Medical Devices & Rad Health | Clean | |
| 10 Jul 2018 – 19 Jul 2018 | Human Drugs | 483 | On file |
| 4 Jun 2018 | Medical Devices & Rad Health | Clean | |
| 18 Apr 2017 | Medical Devices & Rad Health | Clean | |
| 17 Oct 2016 – 25 Oct 2016 | Human Drugs | Clean | |
| 4 Mar 2016 | Medical Devices & Rad Health | Clean | |
| 16 Apr 2015 | Medical Devices & Rad Health | Clean | |
| 9 Mar 2015 – 11 Mar 2015 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Mar 2015
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Michael A Charles, Zachery L Miller
11 Mar 2015
21 CFR 211.192
No written record of investigation
Cited by Michael A Charles, Zachery L Miller
Investigators
FDA investigators tied to this site in the record.
Emmanuel A Dimaano16 insp.
Helen B Ricalde1 insp.
Louis G An1 insp.
Djamila Harouaka1 insp.
Michael A Charles1 insp.
Zachery L Miller1 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 | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 2 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