FDA Inspection
Health Line International CorporationHealth Line International Corporation – FDA Inspection, Nov 16, 2017
Record Details
This FDA Inspection record concerns Health Line International Corporation, with an inspection on November 16, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 46983c25-a7d4-45f3-9db4-b834422ad7c7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1031695
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Health Line International Corporation
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 5, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 19, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Health Line International Corporation
- FDA Inspection 822921 - 2013-03-05
- FDA Inspection 662461 - 2010-05-19
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