Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-22.
At a glance
Inspections
6
Form 483s
2
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 May 2026 – 22 May 2026 | Human Drugs | 483 | On file |
| 3 Dec 2018 – 7 Dec 2018 | Human Drugs | Clean | |
| 12 Dec 2016 – 15 Dec 2016 | Human Drugs | Clean | |
| 1 Nov 2012 | Not recorded | Clean | |
| 5 Feb 2010 | Not recorded | 483 | On file |
| 21 Oct 2004 | Not recorded | Clean |
Investigators
FDA investigators tied to this site in the record.
Jose E Melendez1 insp.
Ariel Cruz Figueroa1 insp.
Zhongren Wu1 insp.
German Rivera1 insp.
Heriberto Negron-Rivera1 insp.
Simone E Pitts1 insp.
Anissa M Vargas1 insp.
Full site report
Get the verbatim findings behind Instituto Massone S.A.'s 2 Form 483s
The full inspection record, as Atlas holds it, 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