483
SAFC Carlsbad Inc.FDA 483 - SAFC Carlsbad Inc. - August 14, 2025
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SAFC Carlsbad Inc., a viral vector manufacturer in Carlsbad, CA, was inspected by the FDA. The inspection revealed a significant failure to follow and establish written procedures for manufacturing equipment, specifically concerning maintenance, replacement, and testing of critical components. This indicates a lapse in quality system controls related to equipment management.
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ID · 6adff0f3-3ab9-43d8-a303-57b470a3ec7a