Drug factory · FDA FEI 1824725
PPL Pharma Solutions Riverview LLC
18655 Krause Street, Riverview, MI, United States
No problems found at FDA's last inspection, Nov 4, 2022.
No Action Indicated: inspectors found no objectionable conditions.
7 drug inspections on record since 2009: 3 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Ponatinib | Makes the active ingredient and tests it | Takeda Pharmaceuticals America, Inc. | 63020-533, 63020-534, 63020-535 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 4, 2022 | No problems found | Drug Quality Assurance | — |
| Nov 2, 2015 | No problems found | Drug Quality Assurance | — |
| Nov 24, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 5, 2012 | No problems found | Drug Quality Assurance | — |
| Jan 25, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 22, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 16, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; label; manufacture; pack; particle size reduction; repack.