483
Libra Industries, LLCFDA 483 - Libra Industries, LLC - August 02, 2019
Record Details
An FDA inspection of Libra Industries Dallas, a device manufacturer, revealed significant deficiencies in their quality system. The firm lacked established procedures for handling customer complaints, including oral complaints and medical device report evaluations. Additionally, procedures for documenting, evaluating, and investigating nonconforming products were not adequately defined or followed.
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ID · 62d7adcb-5ccc-4a3d-8ae9-58ce4d8e932b
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