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Brava, LLC, Miami, FL – FDA Inspections

Inspection records and compliance data for Brava, LLC in Miami, FL. 4 FDA inspections on record (1 OAI), 1 warning letter, last inspected August 10, 2015.

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Company Profile

This profile covers Brava, LLC based in Miami, FL, United States.

FDA Inspection History

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

First inspected September 9, 2010. Last inspected August 10, 2015.

Most cited issue areas

  • Abbreviated requirements / non-significant risk study1 inspection
  • Design control - no procedures1 inspection
  • Lack of or inadequate procedures1 inspection

FDA inspections (4)

DateResultFDA center(s)Insp. #
August 10, 2015NAIMedical Devices & Rad Health · Postmarket Assurance: Devices938041
March 14, 2014OAIMedical Devices & Rad Health · Bioresearch Monitoring870691
April 4, 2011NAIMedical Devices & Rad Health · Postmarket Assurance: Devices718242
September 9, 2010VAIMedical Devices & Rad Health · Compliance: Devices679945
FDA documents

Form 483s (1)

  • Form 483s · March 14, 2014

Warning Letters (1)

  • Warning Letters · March 14, 2014

EIRs (2)

  • EIRs · September 19, 2018
  • EIRs · March 14, 2014
People (2)
Dianiris C. Ayala
Person
Steven D. Silverman
Person
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WEBER MEDICAL GMBH
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Company Information

Name

Brava, LLC

FEI Number

3005643748

Address

14221 SW 142nd Street, Miami, FL 33186-6702, United States

Country

United States

ID: 6771295f-377e-47b8-a0ad-201da75d5b17

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