FDA Inspection
Neuromuscular Engineering & Technology, LlcNeuromuscular Engineering & Technology, Llc – FDA Inspection, May 23, 2012
Record Details
This FDA Inspection record concerns Neuromuscular Engineering & Technology, Llc, with an inspection on May 23, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 23, 2012
- Product Type
- Devices
View Company Profile
ID · b317f144-dde9-4c18-acee-1aa1a61e9715
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 784648
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.25(b)Training records
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 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 28, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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