CPE1 LLCNovember 21, 2022

FDA 483 - CPE1 LLC - November 21, 2022

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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.

Company: CPE1 LLC
Inspection Date: November 21, 2022
Product Type: Device
Office: Office of Medical Device and Radiological Health Division II
Person: Karen M. Rodriguez (investigator)

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ID · 46546703-567a-4ace-b720-29103df454b1