Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-06-27.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Jun 2025 – 27 Jun 2025 | Human Drugs | 483 | View 483 → |
| 11 Jun 2018 – 15 Jun 2018 | Human Drugs | 483 | View 483 → |
| 2 Mar 2015 – 6 Mar 2015 | Human Drugs | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Jun 2025
21 CFR 211.188(b)(11)
Identification of Persons Performing Significant Steps
Cited by Alan A Rivera
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.188(b)(11) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | 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 this site's 2 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