FDA Inspection
Aero-Med LLCAero-Med LLC – FDA Inspection, Oct 26, 2023
Record Details
This FDA Inspection record concerns Aero-Med LLC, with an inspection on October 26, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · be1a1746-b407-4ae5-8af2-b3a7501e291a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1221108
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
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Other FDA inspections of Aero-Med LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 1, 2026 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 21, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Aero-Med LLC
- FDA Inspection 1339660 - 2026-10-01
- FDA Inspection 1076976 - 2018-12-21
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