Biomat USA, Inc. – FDA 483, Jan 9, 2025
Biomat USA, Inc. in Cedar City, UT, a source plasma firm, was cited for significant deficiencies related to equipment qualification, deviation investigations, record-keeping, and standard operating procedures. The inspection revealed failures to document investigations for malfunctioning plasmapheresis machines, incomplete documentation for discrepancies, and a lack of procedures for equipment failures. These issues indicate a systemic breakdown in quality control and record management practices.
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- Denver District Office
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ID · d62f539a-27eb-4316-a12f-5422e72659a4
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