Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-02-13.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Feb 2024 | Medical Devices & Rad Health | Clean | |
| 9 Aug 2022 – 10 Aug 2022 | Medical Devices & Rad Health | Clean | |
| 6 Mar 2018 | Medical Devices & Rad Health | Clean | |
| 9 Aug 2011 | Not recorded | 483 | View 483 → |
| 14 Jun 2010 | Not recorded | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Aug 2011
21 CFR 820.75(b)
Lack/Inad procedure-Monitoring/Control of Validated Proces
Cited by Herminio C Francisco, Binh T Nguyen
14 Jun 2010
21 CFR 806.10(a)(1)
Report of risk to health
Cited by Yvette M Lacour-Davis, Herminio C Francisco
14 Jun 2010
21 CFR 820.50(a)
Evaluation of suppliers, contractors, etc., requirements
Cited by Yvette M Lacour-Davis, Herminio C Francisco
Investigators
FDA investigators tied to this site in the record.
Herminio C Francisco2 insp.
State Agency1 insp.
Kirtida Patel1 insp.
Leonard H Lavi1 insp.
Binh T Nguyen1 insp.
Yvette M Lacour-Davis1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 806.10(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.120 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.86 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Monarch Labs, LLC's 2 Form 483s
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