483
J.M Huber Micropowders, IncJ.M Huber Micropowders, Inc – FDA 483, Jun 25, 2021
Record Details
An FDA inspection of J.M Huber Micropowders, Inc. in La Mirada, CA, revealed significant deficiencies in their manufacturing processes for non-sterile API. The firm was cited for producing batches using unsupported validation data, failing to document deviations, and not calibrating critical equipment. Additionally, the inspection found that GMP-related computerized systems lacked proper validation, indicating a need for improved quality control and adherence to regulatory standards.
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ID · 3e0fd1b3-f761-4982-a483-919a904e486e
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