483
Davryan Laboratories, Inc.Davryan Laboratories, Inc. – FDA 483, Oct 11, 2023
Record Details
An FDA inspection of Davryan Laboratories, Inc. in Porter, IN, conducted from October 10-11, 2023, identified a significant deficiency in the firm's quality system. The company failed to establish adequate procedures for controlling nonconforming Class II finished products. This indicates a lack of proper controls for identifying, documenting, evaluating, segregating, and disposing of products that do not meet specified requirements.
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ID · 4e73e832-f757-4311-986a-08ec33da5b6a
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