Drug factory · FDA FEI 3009255642
Gateway Analytical, LLC>
2009 Kramer Road, Gibsonia, PA, United States
Problems found, fixed voluntarily at FDA's last inspection, Mar 20, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2012: 3 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Aflibercept-Mrbb | Tests it | Valorum Biologics LLC | 85006-2908 |
| Hydrocortisone | Tests it | Eton Pharmaceuticals, Inc. | 71863-116 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 20, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Sep 16, 2022 | No problems found | Drug Quality Assurance | — |
| Jan 15, 2015 | No problems found | Drug Quality Assurance | — |
| Nov 5, 2012 | 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.
Mar 20, 2026 inspection
- Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
Registered with FDA for: analysis.