FDA Inspection
HHS Systems Inc.HHS Systems Inc. – FDA Inspection, Apr 25, 2019
Record Details
This FDA Inspection record concerns HHS Systems Inc., with an inspection on April 25, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b1790dd3-a467-4130-859f-ffbc2949db6c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1087836
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.86Acceptance status
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of HHS Systems Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 18, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for HHS Systems Inc.
- FDA Inspection 1168648 - 2022-03-18
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