FDA Inspection
The Hygenic Company LLC.The Hygenic Company LLC. – FDA Inspection, Jun 29, 2017
Record Details
This FDA Inspection record concerns The Hygenic Company LLC., with an inspection on June 29, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b0ae957f-b223-428e-b39c-6d9aa716578d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1016174
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 820.186QSR
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Other FDA inspections of The Hygenic Company LLC.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 17, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 20, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for The Hygenic Company LLC.
- FDA Inspection 1161392 - 2021-12-17
- FDA Inspection 764076 - 2012-01-20
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