FDA Inspection
Healthline Medical Products, Inc.Healthline Medical Products, Inc. – FDA Inspection, Nov 7, 2008
Record Details
This FDA Inspection record concerns Healthline Medical Products, Inc., with an inspection on November 7, 2008, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 7, 2008
- Product Type
- Devices
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ID · 742dd169-07e7-474f-8396-ac603582b21a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 546029
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.198(a)General
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.100(a)Lack of or inadequate procedures
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 |
| June 16, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 13, 2013 | 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 1014941 - 2017-06-16
- FDA Inspection 822075 - 2013-03-13
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