Drug factory · FDA FEI 3011566408
LSNE-LEON SLU, D/B/A: PCI Pharma Services
CALLE NICOSTRATO VELA, PQ. TECNOLOGICO LEÓN), S/N, M1.1-M1.2, Leon, Spain
Problems found, fixed voluntarily at FDA's last inspection, Mar 21, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2021: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Testosterone | Makes it and tests it | Cipla USA., Inc. | 69097-536, 69097-537 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 21, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 28, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; manufacture; pack.