483
Global Plastics Inc.FDA 483 - Global Plastics Inc. - February 28, 2025
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Record Details
Global Plastics Inc., a contract manufacturer in Indianapolis, IN, received a Form FDA 483 with three observations. The firm failed to correctly translate device designs into production specifications, lacked established procedures for in-process product control, and did not properly maintain device history records. These issues indicate significant deficiencies in the firm's quality system.
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ID · 03db0617-5d1c-42b0-bad4-2a9658d24f4c