483
Jatex, Inc.Jatex, Inc. – FDA 483, Jun 15, 2023
Record Details
An FDA inspection of Jatex, Inc. in Nappanee, IN, revealed two significant observations regarding their quality system. The firm failed to adequately establish procedures for handling complaints, including investigation necessity and documentation, and did not properly establish process controls for a validated manufacturing process, leading to deviations from manufacturer specifications.
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ID · ed638f0c-4fd6-4d5d-aec3-0d14af18d2cd
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