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•United States

The Soule Company, Lutz, FL – FDA Inspections

Inspection records and compliance data for The Soule Company in Lutz, Florida. 4 FDA inspections on record, 1 Form 483, last inspected February 13, 2018.

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Company Profile

This profile covers The Soule Company based in Lutz, Florida, United States.

FDA Inspection History

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

First inspected March 19, 2010. Last inspected February 13, 2018.

Most cited issue areas

  • Documentation2 inspections
  • Lack of or inadequate procedures2 inspections
  • Availability1 inspection

FDA inspections (4)

DateResultFDA center(s)Insp. #
February 13, 2018VAIMedical Devices & Rad Health · Compliance: Devices1042004
September 16, 2013VAIMedical Devices & Rad Health · Compliance: Devices848620
April 20, 2011VAIMedical Devices & Rad Health · Compliance: Devices721205
March 19, 2010VAIMedical Devices & Rad Health · Postmarket Assurance: Devices652112
FDA documents

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

Related Companies (10)

Companies with similar regulatory profiles, compliance history, and operations.

Palm Harbor Medical Inc.
Aurora Surgical, LLC
Care Tech Industries, Inc.
Pierce Surgical Consolidated, Inc.
Vladimir Santos, MD
C2C Development, LLC
NDS Surgical Imaging LLC
Magnificent Medical Equipment, Inc. DBA Tony Riso Company
EDM3 LLC
Special Products Inc
Company Information

Name

The Soule Company

FEI Number

1000525333

Address

26543 wild fern cir, Lutz, Florida 33559, United States

Country

United States

ID: e9d877ee-de9f-44a8-b143-982bf3538b25

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