Drug factory · FDA FEI 1033964
GlaxoSmithKline LLC
1011 North Arendell Ave, Zebulon, NC, United States
No problems found at FDA's last inspection, Feb 20, 2026.
No Action Indicated: inspectors found no objectionable conditions.
9 drug inspections on record since 2009: 7 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Naproxen and Sumatriptan | Tests it, packages it and labels it | Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven | 42847-850 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 20, 2026 | No problems found | Drug Quality Assurance | — |
| Apr 19, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Jan 26, 2018 | No problems found | Drug Quality Assurance | — |
| Apr 21, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Aug 21, 2015 | No problems found | Drug Quality Assurance | — |
| May 3, 2013 | No problems found | Drug Quality Assurance | — |
| Nov 20, 2009 | No problems found | Drug Quality Assurance | — |
| Aug 24, 2009 | No problems found | Drug Quality Assurance | — |
| Aug 24, 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.
Apr 19, 2024 inspection
- 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.
Apr 21, 2016 inspection
- Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. - 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; label; manufacture; pack.