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•United States

The Morel Company, LLC, Batesville, IN – FDA Inspections

Inspection records and compliance data for The Morel Company, LLC in Batesville, Indiana. 3 FDA inspections on record, 1 Form 483, last inspected July 02, 2024.

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Company Profile

This profile covers The Morel Company, LLC based in Batesville, Indiana, United States.

FDA Inspection History

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

First inspected August 27, 2015. Last inspected July 2, 2024.

Most cited issue areas

  • Product rework procedures, Lack of or inadequate procedures3 inspections
  • Design changes - Lack of or Inadequate Procedures1 inspection
  • Design transfer - Lack of or inadequate procedures1 inspection

FDA inspections (3)

DateResultFDA center(s)Insp. #
July 2, 2024VAIMedical Devices & Rad Health · Compliance: Devices1242930
November 1, 2018VAIMedical Devices & Rad Health · Compliance: Devices1070564
August 27, 2015VAIMedical Devices & Rad Health · Compliance: Devices939517
FDA documents

Form 483s (1)

  • Form 483s · November 1, 2018
People (2)
Teresa Kastner
Person
K. Raveendra
Person
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Advanced OrthoPro, Inc.
Sonablate Corp.
Innovize Inc
Paradigm Packaging West, LLC
Okami Medical Inc.
Arc Precision Acquisitions, LLC.
Company Information

Name

The Morel Company, LLC

FEI Number

3010388769

Address

300 Winding Way, Batesville, Indiana 47006, United States

Country

United States

ID: 52396817-9113-4c3c-b344-e318e5ad2859

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