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483
•Indiana Coast Medical LLC•April 2, 2025

FDA 483 - Indiana Coast Medical LLC - April 02, 2025

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Record Details

Indiana Coast Medical LLC, an HCT/P distributor in Valparaiso, IN, was cited for significant deficiencies in its operations. The inspection revealed a lack of established procedures for HCT/P manufacturing, storage, and distribution, as well as failures in evaluating incoming products for contamination. Additionally, the firm's storage areas were not adequately controlled to prevent mix-ups or improper release of HCT/Ps.

Company
Indiana Coast Medical LLC
Inspection Date
April 2, 2025
Product Type
Biologics
Office
Division of Pharmaceutical Quality Operations III
People
  • Gabryelle J. Solverud
  • David A. Moore
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ID · cb1b5933-0d00-4830-b717-5799310fc628

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