Company
United StatesMedical Engineering Laboratories, Inc., Shelby, NC – FDA Inspections
Inspection records and compliance data for Medical Engineering Laboratories, Inc. in Shelby, North Carolina. 2 FDA inspections on record, last inspected April 23, 2015.
Company Profile
This profile covers Medical Engineering Laboratories, Inc. based in Shelby, North Carolina, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected March 22, 2011. Last inspected April 23, 2015.
Most cited issue areas
- DHR - not or inadequately maintained1 inspection
- Lack of or inadequate complaint procedures1 inspection
- Purchasing controls, Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 23, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 930734 |
| March 22, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 717836 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Medical Engineering Laboratories, Inc.
FEI Number
1037861
Address
3039 Longwood Dr, Shelby, North Carolina 28152, United States
Country
United States
ID: 27476709-2a40-4aea-9efd-28469e3ae9b0