Drug factory · FDA FEI 1417338
GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare)
3350 North Ridge Avenue, Arlington Heights, IL, United States
No problems found at FDA's last inspection, Sep 19, 2025.
No Action Indicated: inspectors found no objectionable conditions.
8 drug inspections on record since 2009: 6 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Flotufolastat F-18 | Tests it | Blue Earth Diagnostics | 69932-002 |
| Flurpiridaz F-18 | Tests it | GE Healthcare Inc. | 0407-8787 |
| Flutemetamol F-18 | Tests it | Medi-Physics Inc. dba GE Healthcare. | 17156-067 |
| Indium Cation in-111 | Makes it, makes the active ingredient and tests it | Medi-Physics Inc. dba GE Healthcare. | 17156-021, 17156-251 |
| Iobenguane I-123 | Makes it | Medi-Physics Inc. dba GE Healthcare. | 17156-235 |
| Ioflupane I-123 | Makes it | Medi-Physics Inc. dba GE Healthcare. | 17156-210 |
| Mebrofenin | Tests it | Bracco Diagnostics Inc. | 0270-0083 |
| Rubidium Cation Rb-82 | Makes it, tests it, packages it and labels it | Bracco Diagnostics Inc. | 0270-0091 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 19, 2025 | No problems found | Drug Quality Assurance | — |
| Mar 8, 2024 | Problems found, fixed voluntarily | Bioresearch Monitoring | 1 |
| Jan 24, 2020 | No problems found | Drug Quality Assurance | — |
| Mar 5, 2015 | No problems found | Drug Quality Assurance | — |
| Jul 9, 2013 | No problems found | Drug Quality Assurance | — |
| Feb 13, 2012 | No problems found | Drug Quality Assurance | — |
| Apr 8, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Jul 2, 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.
Mar 8, 2024 inspection
- Ensuring compliance with plan and protocol 21 CFR 312.50
Failure to ensure that an investigation was conducted in accordance with the general investigational plan and protocols as specified in the IND.
Apr 8, 2010 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. - 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. - Complete test data included in records 21 CFR 211.194(a)
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Registered with FDA for: analysis; api manufacture; label; manufacture; pack.