Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-09-29.
At a glance
Inspections
4
Form 483s
2
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Sep 2025 – 29 Sep 2025 | Biologics | 483 | View 483 → |
| 20 Sep 2023 – 25 Sep 2023 | Biologics | 483 | On file |
| 22 Aug 2019 – 26 Aug 2019 | Biologics | Clean | |
| 20 Apr 2017 – 26 Apr 2017 | Biologics | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Sep 2025
21 CFR 211.188(b)(2)
Identity of major equipment and lines used
Cited by Shafiq Ahadi, Lizaida Perez
29 Sep 2025
21 CFR 314.80(b)
Failure to develop written procedures
Cited by Shafiq Ahadi, Lizaida Perez
Investigators
FDA investigators tied to this site in the record.
Sarah M Forney2 insp.
Shafiq Ahadi1 insp.
Lizaida Perez1 insp.
Christine Harman1 insp.
Graeme E Price1 insp.
Phillip C Thai1 insp.
Alan G Baer1 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 | 1x |
| 21 CFR 211.188(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Minaris Regenerative Medicine, LLC'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