FDA Inspection
Integrity Systems LLCIntegrity Systems LLC – FDA Inspection, Jun 6, 2017
Record Details
This FDA Inspection record concerns Integrity Systems LLC, with an inspection on June 6, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Bonnie E. Conley (Issuing Officer)
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ID · 97e2b0c5-6f08-48c2-8339-a11cc1d2dd6d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1013014
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.70(i)Documentation of software validation
- 21 CFR 820.184DHR content
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Other FDA inspections of Integrity Systems LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 6, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Integrity Systems LLC
- FDA Inspection 1292548 - 2025-11-06
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