FDA Inspection
Laboratorios Leon Farma SAULaboratorios Leon Farma SAU – FDA Inspection, May 25, 2018
Record Details
This FDA Inspection record concerns Laboratorios Leon Farma SAU, with an inspection on May 25, 2018, issued by the Office of Inspections and Investigations, covering human drugs.
- People
- James Norman (Issuing Officer)
- Michael L. Casner (Company Rep)
- Seema S. Singh (Issuing Officer)
View Company Profile
ID · 8e283eef-173e-4ae1-8f63-79d43d87d6dd
Inspection Facts
- Inspection number
- 1053237
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.30(a)Design control - no procedures
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Other FDA inspections of Laboratorios Leon Farma SAU
10| Date | Classification | Office | Project area |
|---|---|---|---|
| January 15, 2026 | Not classified | Office of Inspections and Investigations | Compliance: Medical Devices |
| July 11, 2025 | Not classified | Office of Inspections and Investigations | |
| January 17, 2024 | Not classified | Office of Inspections and Investigations | |
| March 31, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 25, 2021 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Laboratorios Leon Farma SAU
- FDA Inspection 1289982 - 2026-01-15
- FDA Inspection 1275596 - 2025-07-11
- FDA Inspection 1314992 - 2024-01-17
- FDA Inspection 1206317 - 2023-03-31
- FDA Inspection 1215828 - 2021-02-25
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