FDA Inspection
Iovance Biotherapeutics Manufacturing LLCIovance Biotherapeutics Manufacturing LLC – FDA Inspection, Nov 20, 2025
Record Details
This FDA Inspection record concerns Iovance Biotherapeutics Manufacturing LLC, with an inspection on November 20, 2025, issued by the Philadelphia District Office, covering biologics.
- Inspection Date
- November 20, 2025
- Product Type
- Biologics
- Person
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ID · a1134f9d-9275-4a27-9a0f-2c8073cc493e
Inspection Facts
- Inspection number
- 1293344
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
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Other FDA inspections of Iovance Biotherapeutics Manufacturing LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 25, 2023 | Not classified | Philadelphia District Office |
Other documents for Iovance Biotherapeutics Manufacturing LLC
- FDA Inspection 1230147 - 2023-08-25
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