Drug factory · FDA FEI 3002804236
West Services and Solutions LLC
530 Herman O West Dr, Exton, PA, United States
No problems found at FDA's last inspection, Mar 9, 2026.
No Action Indicated: inspectors found no objectionable conditions.
5 drug inspections on record since 2009: 4 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Obiltoxaximab | Tests it | Elusys Therapeutics, Inc. | 69604-204 |
| Pegcetacoplan | Tests it | Apellis Pharmaceuticals, Inc. | 73606-020 |
| Talimogene Laherparepvec | Tests it | Amgen Inc | 55513-078, 55513-079 |
| Teplizumab | Tests it | Provention Bio, Inc. | 73650-316 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 9, 2026 | No problems found | Drug Quality Assurance | — |
| May 18, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Jan 22, 2016 | No problems found | Drug Quality Assurance | — |
| Mar 20, 2012 | No problems found | Drug Quality Assurance | — |
| Aug 25, 2009 | 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.
May 18, 2023 inspection
- Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. - input/output verification 21 CFR 211.68(b)
Input to and output from records or data are not checked for accuracy.
Registered with FDA for: analysis.