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CosmoFrance, Inc., Miami, FL – FDA Inspections

Inspection records and compliance data for CosmoFrance, Inc. in Miami, Florida. 3 FDA inspections on record, 1 Form 483, last inspected September 16, 2021.

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Company Profile

This profile covers CosmoFrance, Inc. based in Miami, Florida, United States.

FDA Inspection History

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

First inspected October 30, 2014. Last inspected September 16, 2021.

Most cited issue areas

  • Lack of or inadequate complaint procedures2 inspections
  • Lack of Written MDR Procedures2 inspections
  • Documentation1 inspection

FDA inspections (3)

DateResultFDA center(s)Insp. #
September 16, 2021VAIMedical Devices & Rad Health · Compliance: Devices1151857
April 2, 2019VAIMedical Devices & Rad Health · Postmarket Assurance: Devices1084958
October 30, 2014VAIMedical Devices & Rad Health · Postmarket Assurance: Devices910062
FDA documents

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

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Kollsut International Inc.
Southeast Signal Inc.
Farrell C. Tyson, MD
Company Information

Name

CosmoFrance, Inc.

FEI Number

3007895168

Address

1444 Biscayne Blvd Ste 218, Miami, Florida 33132, United States

Country

United States

ID: 7d90be73-0aee-4bbc-b296-8d1ba63e8ba2

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