FDA Inspection
Norwood Medical, LLCNorwood Medical, LLC – FDA Inspection, Nov 15, 2016
Record Details
This FDA Inspection record concerns Norwood Medical, LLC, with an inspection on November 15, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b44c3874-ed48-4589-8d4f-d99a2c922e11
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 998371
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
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Other FDA inspections of Norwood Medical, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 27, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 16, 2020 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Norwood Medical, LLC
- FDA Inspection 1187356 - 2022-10-27
- FDA Inspection 1117584 - 2020-01-16
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