FDA Inspection
LKC Technologies, Inc.LKC Technologies, Inc. – FDA Inspection, Mar 29, 2018
Record Details
This FDA Inspection record concerns LKC Technologies, Inc., with an inspection on March 29, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 8fe26ffe-5e01-4be2-94f7-52d01fc9781f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1046213
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
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Other FDA inspections of LKC Technologies, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 17, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 5, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for LKC Technologies, Inc.
- FDA Inspection 860090 - 2013-12-17
- FDA Inspection 646653 - 2010-03-05
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