Overview
- 9 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-01-15.
At a glance
Inspections
9
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Jan 2026 – 15 Jan 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 7 Jul 2025 – 11 Jul 2025 | Human Drugs | 483 | On file |
| 27 Mar 2023 – 31 Mar 2023 | Human Drugs | Clean | |
| 5 Jun 2019 – 11 Jun 2019 | Human Drugs | Clean | |
| 21 May 2018 – 25 May 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 24 Mar 2014 – 28 Mar 2014 | Human Drugs | Clean | |
| 9 Feb 2012 | Not recorded | 483 | On file |
| 26 Feb 2009 | Not recorded | 483 | On file |
| 17 Jan 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
25 May 2018
21 CFR 820.30(a)
Design control - no procedures
Cited by Seema S Singh, Michael L Casner, James Norman
25 May 2018
21 CFR 820.30(a)
Design control - no procedures
Cited by Seema S Singh, Michael L Casner, James Norman
Investigators
FDA investigators tied to this site in the record.
Joshua J Silvestri1 insp.
Gajendiran Mahadevan1 insp.
Dennis Cantellops Paite1 insp.
Vilmary Negron Rodriguez1 insp.
Seema S Singh1 insp.
Michael L Casner1 insp.
James Norman1 insp.
Helen B Ricalde1 insp.
Sina Shojaee1 insp.
Sanket N Patel1 insp.
Susanna E Ford1 insp.
Demitria J Xiradakis1 insp.
Luis M Burgos Medero1 insp.
Brooke K Higgins1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Laboratorios Leon Farma SAU's 5 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