Drug factory · FDA FEI 3011626127
PCL Research&Manufacturing srl
Via Francesco Saverio Fabri, 127/1, Medicina, Italy
Matched to FDA's records by company name, because this plant's registration on the label has expired.
Problems found, fixed voluntarily at FDA's last inspection, Oct 20, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2019: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Trimipramine | Tests it | Breckenridge Pharmaceutical, Inc. | 51991-944, 51991-945, 51991-946 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 20, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 22, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis.