483
Molecular Biologicals, LLCFDA 483 - Molecular Biologicals, LLC - September 26, 2019
Record Details
Molecular Biologicals, LLC, an initial importer in Pasadena, TX, was cited for multiple significant quality system deficiencies during an FDA inspection from September 10-26, 2019. The firm lacked established written procedures for medical device reporting, complaint handling, corrective and preventive actions, control and distribution of finished devices, and acceptance of incoming products. These observations indicate a fundamental absence of critical quality system controls.
- Office
- Dallas District Office
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ID · 8ad422b5-92bc-422b-a627-d1414e6875f4