FDA Inspection
HNM MedicalHNM Medical – FDA Inspection, May 9, 2018
Record Details
This FDA Inspection record concerns HNM Medical, with an inspection on May 9, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 77ce8e2e-cd4d-4bd7-9c4a-c9d9c13d0538
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1051266
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of HNM Medical
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 11, 2023 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 2, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for HNM Medical
- FDA Inspection 1195102 - 2023-01-11
- FDA Inspection 987024 - 2016-09-02
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