Company
United StatesLKC Technologies, Inc., Gaithersburg, MD – FDA Inspections
Inspection records and compliance data for LKC Technologies, Inc. in Gaithersburg, Maryland. 3 FDA inspections on record, 1 Form 483, last inspected March 29, 2018.
Company Profile
This profile covers LKC Technologies, Inc. based in Gaithersburg, Maryland, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected March 5, 2010. Last inspected March 29, 2018.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Design validation - user needs and intended uses1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 29, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1046213 |
| December 17, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 860090 |
| March 5, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 646653 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
LKC Technologies, Inc.
FEI Number
1119189
Address
2 Professional Dr Ste 222, Gaithersburg, Maryland 20879, United States
Country
United States
ID: 5721e30b-8087-4450-8f88-bec14f6d71c9