FDA Inspection
Healthline Medical Products, Inc.Healthline Medical Products, Inc. – FDA Inspection, Jun 16, 2017
Record Details
This FDA Inspection record concerns Healthline Medical Products, Inc., with an inspection on June 16, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · be7a521e-828e-409e-9d3c-e6e0d38558d2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1014941
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.184DHR content
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.50(a)(1)Documented evaluation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Healthline Medical Products, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| November 5, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 1, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 24, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 13, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 8, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Healthline Medical Products, Inc.
- FDA Inspection 1254996 - 2024-11-05
- FDA Inspection 1209742 - 2023-06-01
- FDA Inspection 1107841 - 2019-10-24
- FDA Inspection 822075 - 2013-03-13
- FDA Inspection 637368 - 2010-01-08
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