FDA Inspection
Huestis Machine CorporationHuestis Machine Corporation – FDA Inspection, Jun 24, 2011
Record Details
This FDA Inspection record concerns Huestis Machine Corporation, with an inspection on June 24, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Huestis Machine Corporation
- Inspection Date
- June 24, 2011
- Product Type
- Devices
View Company Profile
ID · 00675ec7-58e5-4e36-bbc7-9a0e703a94df
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 735374
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.80(e)Documentation
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.70(i)Documentation of software validation
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Other FDA inspections of Huestis Machine Corporation
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 30, 2022 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| September 15, 2017 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| March 27, 2014 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| May 13, 2013 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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