FDA Inspection
ACI Medical LLCACI Medical LLC – FDA Inspection, Aug 17, 2023
Record Details
This FDA Inspection record concerns ACI Medical LLC, with an inspection on August 17, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 44cde3e9-e896-4916-8ab4-92b76b476122
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1215085
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.184(f)DHR - UDI not included
Full citation text and observation details available on the Dashboard.
Other FDA inspections of ACI Medical LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 24, 2026 | Not classified | Los Angeles District Office | |
| July 16, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for ACI Medical LLC
- FDA Inspection 1319316 - 2026-04-24
- FDA Inspection 840350 - 2013-07-16
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