483
Gregory Manufacturing, Inc.Gregory Manufacturing, Inc. – FDA 483, Apr 2, 2026
Record Details
During an inspection, Gregory Manufacturing, Inc. in Holyoke, MA, was cited for a single observation related to their corrective and preventative action procedures. The firm failed to initiate a corrective action report after mislabeled devices were returned by a customer, which was a requirement under their own written procedures. This indicates a lapse in their quality system regarding nonconformity management.
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