Overview
- 8 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-02.
At a glance
Inspections
8
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Feb 2026 – 2 Mar 2026 | Human Drugs | 483 | View 483 → |
| 1 Aug 2023 – 10 Aug 2023 | Human Drugs | 483 | View 483 → |
| 28 Jul 2021 – 12 Aug 2021 | Human Drugs | 483 | On file |
| 26 Feb 2020 – 10 Mar 2020 | Human Drugs | WL | View 483 → |
| 16 Apr 2018 – 27 Apr 2018 | Human Drugs | 483 | View 483 → |
| 28 May 2013 – 29 May 2013 | Human Drugs | 483 | View 483 → |
| 6 Aug 2004 | Not recorded | Clean | |
| 20 Dec 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
2 Mar 2026
21 CFR 211.170(b)
Reserve samples identified, representative, stored
Cited by Ruben C Quintana
Investigators
FDA investigators tied to this site in the record.
Craig D Zagata2 insp.
Ruben C Quintana1 insp.
Brandy N Lepage1 insp.
Frederick Razzaghi1 insp.
Ko U Min1 insp.
Daniel J Min1 insp.
Vlada Matusovsky1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.130(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.122(g)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.94(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Coupler LLC's 6 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