483
MONOCENT INC.MONOCENT INC. – FDA 483, Aug 19, 2021
Record Details
An FDA inspection of MONOCENT INC. in Chatsworth, CA, from August 17-19, 2021, revealed a significant issue with process control procedures. The firm failed to adequately establish procedures for recording in-process non-conformities during the relabeling and repacking of medical devices. This indicates a lack of robust controls to ensure product conformance to specifications.
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ID · 82626fa5-2967-4d7f-91ae-281dbab414e1
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