Associates of Cape Cod, Inc.October 21, 2021

FDA 483 - Associates of Cape Cod, Inc. - October 21, 2021

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Record Details

Associates of Cape Cod, Inc., a manufacturer in East Falmouth, MA, was inspected by the FDA. The inspection revealed a significant issue regarding the firm's quality system, specifically the inadequate documentation of corrective and preventive action activities. This included a failure to document CAPA for a specific recall, indicating a lapse in adherence to their own established procedures.

Company: Associates of Cape Cod, Inc.
Inspection Date: October 21, 2021
Product Type: Other
Office: Division of Northeast Imports
Person: Nabil Nakhoul

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