FDA Inspection
Cirrus Healthcare Products, LLCCirrus Healthcare Products, LLC – FDA Inspection, Apr 26, 2018
Record Details
This FDA Inspection record concerns Cirrus Healthcare Products, LLC, with an inspection on April 26, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- James W. Whitney (Issuing Officer)
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ID · 20a59218-071a-4720-964b-49aada1a4801
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1049779
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.50(b)Supplier notification of changes
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
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