Drug factory · FDA FEI 1826582
W. R. Grace & Co.-Conn.
1421 Kalamazoo St, South Haven, MI, United States
No problems found at FDA's last inspection, Mar 2, 2026.
No Action Indicated: inspectors found no objectionable conditions.
6 drug inspections on record since 2009: 6 with no problems, 0 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Hydrocortisone and Pramoxine | Makes the active ingredient | Sebela Pharmaceuticals Inc. | 54766-829 |
| Larotrectinib | Makes the active ingredient | Loxo Oncology, Inc. | 71777-392 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 2, 2026 | No problems found | Drug Quality Assurance | — |
| Dec 8, 2017 | No problems found | Drug Quality Assurance | — |
| May 14, 2014 | No problems found | Drug Quality Assurance | — |
| Jan 19, 2012 | No problems found | Drug Quality Assurance | — |
| Nov 19, 2010 | No problems found | Drug Quality Assurance | — |
| Jul 22, 2009 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: api manufacture.