FDA Inspection
Mini Lap Technologies Inc.Mini Lap Technologies Inc. – FDA Inspection, Jun 23, 2014
Record Details
This FDA Inspection record concerns Mini Lap Technologies Inc., with an inspection on June 23, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Mini Lap Technologies Inc.
- Inspection Date
- June 23, 2014
- Product Type
- Devices
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ID · d903c0b4-a333-48bf-964a-a1757f20286a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 886172
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.33(a)Failure to Submit Annual Reports
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Mini Lap Technologies Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 18, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 9, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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