Drug factory · FDA FEI 3003812585
Catalent U.k. Swindon Zydis Limited
Frankland Road, Blagrove, Swindon, United Kingdom
Problems found, fixed voluntarily at FDA's last inspection, Oct 10, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2011: 1 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Fingolimod | Makes it and tests it | Cycle Pharmaceuticals Ltd. | 70709-062, 70709-065 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 10, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 15, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 20, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 15, 2016 | No problems found | Drug Quality Assurance | — |
| Sep 12, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Nov 18, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Sep 12, 2014 inspection
- Extent of discrepancy, failure investigations 21 CFR 211.192
Investigations of an unexplained discrepancy did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed. - Protective Apparel Not Worn 21 CFR 211.28(a)
Protective apparel is not worn as necessary to protect drug products from contamination. - Written calibration / inspection records not kept 21 CFR 211.68(a)
Records of the calibration checks of automatic, mechanical or electronic equipment, including computers or related systems are not maintained.
Nov 18, 2011 inspection
- SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions. - Procedures to be written and followed 21 CFR 211.198(a)
Procedures describing the handling of all written and oral complaints regarding a drug product are not established, written, and followed.
Registered with FDA for: analysis; manufacture; pack.