FDA Inspection
Neuromuscular Engineering & Technology, LlcNeuromuscular Engineering & Technology, Llc – FDA Inspection, May 28, 2015
Record Details
This FDA Inspection record concerns Neuromuscular Engineering & Technology, Llc, with an inspection on May 28, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 28, 2015
- Product Type
- Devices
View Company Profile
ID · f24520b6-ab2b-4487-af28-c5501d4d8b9f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 927384
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Neuromuscular Engineering & Technology, Llc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 23, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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