483
Chemtron Biotech, IncChemtron Biotech, Inc – FDA 483, Mar 18, 2022
Record Details
An FDA inspection of Chemtron Biotech, Inc. in San Diego, CA, conducted from March 14-18, 2022, identified a significant issue regarding process validation. The firm failed to adequately validate a manufacturing process, specifically by not performing operational qualification for equipment used in producing in-vitro diagnostic test kits. This lapse indicates a potential risk to the quality and reliability of their finished IVD products.
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ID · 0a1eec23-3b69-4a67-94be-93b5756c5af0
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