Drug factory · FDA FEI 3003262904
Glaxo Operations UK Ltd
Priory Street, Ware, United Kingdom
Problems found, fixed voluntarily at FDA's last inspection, Dec 6, 2024.
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 2009: 3 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Naproxen and Sumatriptan | Makes it and tests it | Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven | 42847-850 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 6, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 6, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Jan 25, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 10, 2015 | No problems found | Drug Quality Assurance | — |
| Sep 12, 2014 | No problems found | Drug Quality Assurance | — |
| Apr 25, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 30, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Jul 21, 2009 | 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.
Sep 6, 2019 inspection
- Procedures for non-sterile drug products 21 CFR 211.113(a)
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established.
Mar 30, 2012 inspection
- Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. - Storage under appropriate conditions 21 CFR 211.142(b)
Drug products are not stored under appropriate conditions of temperature and humidity so that their identity, strength, quality, and purity are not affected. - Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. - Complaint Handling Procedure 21 CFR 211.198(a)
Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
Registered with FDA for: analysis; api manufacture; label; manufacture; pack; particle size reduction.