Drug factory · FDA FEI 3005292384
GE Healthcare (Shanghai) Co Ltd.
No. 1 Niudun Road, China (Shanghai) Pilot Free Trade Zone, China
Problems found, fixed voluntarily at FDA's last inspection, Oct 30, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2008: 1 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Gadodiamide | Makes it, packages it and labels it | GE Healthcare Inc. | 0407-0690 |
| Gadolinium Cation (3+) | Makes it, tests it, packages it and labels it | GE Healthcare Inc. | 0407-2943 |
| Iodixanol | Makes it | GE Healthcare Inc. | 0407-2222, 0407-2223 |
| Iohexol | Makes it | GE Healthcare Inc. | 0407-1412, 0407-1413, 0407-1414 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 30, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 10, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 12, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 8, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Apr 15, 2011 | No problems found | Drug Quality Assurance | — |
| Oct 17, 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.
Nov 8, 2013 inspection
- 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. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and 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.
Registered with FDA for: analysis; label; manufacture; pack.