FDA Inspection
Falck Medical IncorporatedFalck Medical Incorporated – FDA Inspection, Aug 21, 2023
Record Details
This FDA Inspection record concerns Falck Medical Incorporated, with an inspection on August 21, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e9fa5d83-bd3b-4d23-8679-85e28c523faa
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1216090
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
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Other FDA inspections of Falck Medical Incorporated
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 18, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 29, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Falck Medical Incorporated
- FDA Inspection 1296642 - 2025-12-18
- FDA Inspection 959094 - 2016-01-29
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