Drug factory · FDA FEI 3008424653
Shire Human Genetic Therapies, Inc.
200 Riverpark Drive, North Reading, MA, United States
No problems found at FDA's last inspection, Jan 5, 2017.
No Action Indicated: inspectors found no objectionable conditions.
4 drug inspections on record since 2011: 2 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Apadamtase Alfa | Tests it | Takeda Pharmaceuticals America, Inc. | 64764-140, 64764-145 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 5, 2017 | No problems found | Drug Quality Assurance | — |
| Jan 30, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 6, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 16, 2011 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; manufacture.