Drug factory · FDA FEI 1000122198
Advanced Therapies, LLC
4000 S 26TH St, , Philadelphia, PA, United States
No problems found at FDA's last inspection, Feb 7, 2025.
No Action Indicated: inspectors found no objectionable conditions.
10 drug inspections on record since 2010: 4 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Lifileucel | Makes it | Iovance Biotherapeutics Inc. | 73776-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 7, 2025 | No problems found | Drug Quality Assurance | — |
| Feb 7, 2025 | No problems found | Drug Quality Assurance | — |
| Jan 22, 2020 | No problems found | Drug Quality Assurance | — |
| Jan 22, 2020 | No problems found | Drug Quality Assurance | — |
| Apr 17, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 6 |
| Apr 17, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 6 |
| Aug 24, 2012 | No problems found | Drug Quality Assurance | — |
| Aug 24, 2012 | No problems found | Drug Quality Assurance | — |
| Jan 6, 2010 | No problems found | Drug Quality Assurance | — |
| Jan 6, 2010 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Apr 17, 2015 inspection
- Deviations from laboratory control requirements 21 CFR 211.160(a)
Deviations from written test procedures are not justified. - Deviations from laboratory control requirements 21 CFR 211.160(a)
Deviations from written test procedures are not justified. - Complete test data included in records 21 CFR 211.194(a)
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. - Complete test data included in records 21 CFR 211.194(a)
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Registered with FDA for: manufacture.