FDA Inspection
LSVT Global, LLCLSVT Global, LLC – FDA Inspection, Jul 17, 2018
Record Details
This FDA Inspection record concerns LSVT Global, LLC, with an inspection on July 17, 2018, issued by the Denver District Office, covering medical devices & rad health.
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ID · 41f53fc6-3d11-4dc4-9665-9d55f78d3893
Inspection Facts
- Inspection number
- 1060603
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.25(b)Training records
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(g)Design validation - software validation not performed
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
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Other FDA inspections of LSVT Global, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 6, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for LSVT Global, LLC
- FDA Inspection 1102891 - 2019-08-06
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