Drug factory · FDA FEI 3002806562
Pharmaron Manufacturing Services (UK) Limited
Windmill Industrial Estate, Shotton Lane, Cramlington, United Kingdom
Problems found, fixed voluntarily at FDA's last inspection, Feb 24, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2012: 0 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Buprenorphine and Naloxone | Makes the active ingredient | Dr. Reddy's Laboratories Inc. | 43598-579, 43598-580, 43598-581 +1 |
| Nitisinone | Makes the active ingredient | Cycle Pharmaceuticals Ltd. | 70709-000, 70709-002, 70709-005 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 24, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 24, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 11, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 15, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.