CATALENT U.K. SWINDON ZYDIS LIMITED — FDA Facility Profile
CATALENT U.K. SWINDON ZYDIS LIMITED is an FDA-registered facility (FEI 3003812585) located in Wiltshire, GB. Registered operations: ANALYSIS; MANUFACTURE; PACK. RegDataLab tracks 8 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Oct 10, 2024: Voluntary Action Indicated (VAI)
- Inspections on record
- 8 (7 VAI, 1 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Import refusals
- 5
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Oct 10, 2024 | Voluntary Action Indicated (VAI) | No citations listed |
| Jun 15, 2023 | Voluntary Action Indicated (VAI) | No citations listed |
| Feb 20, 2020 | Voluntary Action Indicated (VAI) | No citations listed |
| Jul 26, 2018 | Voluntary Action Indicated (VAI) | No citations listed |
| Sep 15, 2016 | No Action Indicated (NAI) | No citations listed |
| Sep 6, 2016 | Voluntary Action Indicated (VAI) | No citations listed |
| Sep 12, 2014 | Voluntary Action Indicated (VAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) Protective Apparel Not Worn (21 CFR 211.28(a)) Written calibration / inspection records not kept (21 CFR 211.68(a)) Extent of discrepancy, failure investigations (21 CFR 211.192) |
| Nov 18, 2011 | Voluntary Action Indicated (VAI) | SOPs not followed / documented (21 CFR 211.100(b)) Procedures to be written and followed (21 CFR 211.198(a)) |
Facility details
- Company
- Catalent U.K. Swindon Zydis Limited
- Location
- Wiltshire (GB)
- Registration Expires
- Dec 31, 2027
- Operations
- ANALYSIS; MANUFACTURE; PACK
- Source
- decrs