Drug factory · FDA FEI 3002807216
Patheon UK Limited
Kingfisher Drive, Swindon, United Kingdom
Problems found, fixed voluntarily at FDA's last inspection, Jul 7, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
8 drug inspections on record since 2008: 0 with no problems, 8 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Sumatriptan | Makes it | Zogenix, Inc. | 43376-104, 43376-106 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 7, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 17, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 1, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 8, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Sep 12, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Jul 20, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 24, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 9, 2008 | Problems found, fixed voluntarily | 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.
May 8, 2015 inspection
- Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed. - Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. - Reactive/Additive/Absorptive Containers/Closures 21 CFR 211.94(a)
Drug product containers or closures are reactive and additive so as to alter the safety, identity, strength, quality, and purity of the drug beyond the official or established requirements.
Sep 12, 2014 inspection
- Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. - Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up. - Cleaning System 21 CFR 211.42(c)(10)(v)
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
Registered with FDA for: analysis; label; manufacture; pack; sterilize.