FDA Inspection
ACS, LLCACS, LLC – FDA Inspection, Dec 2, 2025
Record Details
This FDA Inspection record concerns ACS, LLC, with an inspection on December 2, 2025, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e7842107-b912-4430-b4b2-25d755632f3e
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1295314
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
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