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•United States

Strata Skin Sciences, Inc., Carlsbad, CA – FDA Inspections

Inspection records and compliance data for Strata Skin Sciences, Inc. in Carlsbad, California. 9 FDA inspections on record, 2 Form 483s, 1 warning letter, last inspected August 22, 2024.

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Company Profile

This profile covers Strata Skin Sciences, Inc. based in Carlsbad, California, United States.

FDA Inspection History

FDA inspections
9
OAI
0
VAI
6
NAI
3
Form 483s
2
Warning letters
1

First inspected September 11, 2009. Last inspected August 22, 2024.

Most cited issue areas

  • Documentation2 inspections
  • Report of Death or Serious Injury2 inspections
  • Complaints1 inspection

FDA inspections (9)

DateResultFDA center(s)Insp. #
August 22, 2024VAIMedical Devices & Rad Health · Compliance: Devices1229432
September 30, 2021NAIMedical Devices & Rad Health · Postmarket Assurance: Devices1153813
February 21, 2019VAIMedical Devices & Rad Health · Postmarket Assurance: Devices1080043
December 16, 2016VAIMedical Devices & Rad Health · Postmarket Assurance: Devices995149
June 16, 2015VAIMedical Devices & Rad Health · Compliance: Devices928601
February 4, 2015NAIMedical Devices & Rad Health · Bioresearch Monitoring913420
September 24, 2013VAIMedical Devices & Rad Health · Compliance: Devices849855
October 12, 2012VAIMedical Devices & Rad Health · Postmarket Assurance: Devices803929
September 11, 2009NAIMedical Devices & Rad Health · Bioresearch Monitoring614257
FDA documents

Form 483s (3)

  • Form 483s · August 22, 2024
  • Form 483s · September 30, 2021
  • Form 483s · June 16, 2015

Warning Letters (1)

  • Warning Letters · August 22, 2011
People (4)
Kirk D. Sooter
Person
Dennis McGrath
Person
Shaquenta Perkins
Person
Stephen R. Souza
Person
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Company Information

Name

Strata Skin Sciences, Inc.

FEI Number

3002942014

Address

2375 Camino Vida Roble Ste B, Carlsbad, California 92011, United States

Country

United States

ID: 593e4318-f3ce-402a-a9cb-da6b2e9086d7

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