FDA Inspection
Galaxy Therapeutics, Inc.Galaxy Therapeutics, Inc. – FDA Inspection, Sep 1, 2026
Record Details
This FDA Inspection record concerns Galaxy Therapeutics, Inc., with an inspection on September 1, 2026, issued by the San Francisco District Office, covering medical devices & rad health.
- Company
- Galaxy Therapeutics, Inc.
- Inspection Date
- September 1, 2026
- Product Type
- Medical Devices & Rad Health
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ID · d0293da9-cacd-4556-874f-22c70dc5ff00
Inspection Facts
- Inspection number
- 1333876
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 812.140(b)(2)Sponsor device disposition records inadequate
- 21 CFR 812.140(b)(2)Sponsor device shipment records inadequate
- 21 CFR 812.40Sponsors' general responsibilities
- 21 CFR 812.43(c)No investigator agreement
- 21 CFR 812.43(d)Monitors not qualified
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Other FDA inspections of Galaxy Therapeutics, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 30, 2026 | Not classified | San Francisco District Office | Project Evaluation: Devices |
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