FDA Inspection
Thrombolex IncThrombolex Inc – FDA Inspection, Mar 30, 2023
Record Details
This FDA Inspection record concerns Thrombolex Inc, with an inspection on March 30, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 5201dfab-0ae0-41a0-bdcf-7f3d290eec5f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1201201
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
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Other FDA inspections of Thrombolex Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 13, 2026 | Not classified | Philadelphia District Office |
Other documents for Thrombolex Inc
- FDA Inspection 1308330 - 2026-03-13
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