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Eclipse Medcorp, LLC, Lewisville, TX – FDA Inspections

Inspection records and compliance data for Eclipse Medcorp, LLC in Lewisville, Texas. 4 FDA inspections on record (2 OAI), 1 Form 483, last inspected November 09, 2018.

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Company Profile

This profile covers Eclipse Medcorp, LLC based in Lewisville, Texas, United States.

FDA Inspection History

FDA inspections
4
OAI
2
VAI
2
NAI
0
Form 483s
1
Warning letters
0

First inspected December 15, 2014. Last inspected November 9, 2018.

Most cited issue areas

  • Lack of or inadequate procedures2 inspections
  • DHR - not or inadequately maintained1 inspection
  • Evaluation and Selection, Suppliers, Contractors, etc.1 inspection

FDA inspections (4)

DateResultFDA center(s)Insp. #
November 9, 2018VAIMedical Devices & Rad Health · Compliance: Devices1071526
August 5, 2016VAIMedical Devices & Rad Health · Compliance: Devices981033
August 13, 2015OAIMedical Devices & Rad Health · Compliance: Devices942433
December 15, 2014OAIMedical Devices & Rad Health · Radiation Control and Health Safety Act907791
FDA documents

No Form 483s, Warning Letters or EIRs on record.

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Juan Bartolomei, MD
Company Information

Name

Eclipse Medcorp, LLC

FEI Number

3009032449

Address

5916 Stone Creek Dr Ste 120, Lewisville, Texas 75056, United States

Country

United States

ID: 5245c90b-f0fe-46a5-9834-aa42f2d274b0

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