Drug factory · FDA FEI 3002442738
Rosemont Pharmaceuticals Limited
Rosemont House Yorkdale Industrial Park, Braithwaite Street, Leeds, United Kingdom
No problems found at FDA's last inspection, Apr 24, 2026.
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 |
|---|---|---|---|
| Clobazam | Makes it | Lundbeck Pharmaceuticals LLC | 67386-313, 67386-314, 67386-315 |
| Simvastatin | Makes it | Salerno Pharmaceuticals Co. | 29273-401, 29273-402 |
| Tamoxifen | Makes it, tests it, packages it and labels it | Mayne Pharma Inc. | 51862-682 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 24, 2026 | No problems found | Drug Quality Assurance | — |
| Feb 8, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 12, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Oct 13, 2011 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Dec 12, 2014 inspection
- Results not used for expiration dates, storage cond. 21 CFR 211.166(a)
Results of stability testing are not used in determining appropriate storage conditions and expiration dates.
Registered with FDA for: analysis; label; manufacture; pack.