483
CPE1 LLCCPE1 LLC – FDA 483, Nov 21, 2022
Record Details
An FDA inspection of InNeuroCo, Inc. in Pembroke Pines, FL, revealed significant deficiencies in the firm's complaint handling procedures. The company failed to adequately establish and implement its complaint handling process, specifically regarding the trending of complaints by type and lot number, and maintaining complete complaint investigation records. These issues indicate a breakdown in their quality system for managing customer feedback and potential product issues.
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ID · 46546703-567a-4ace-b720-29103df454b1
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