Retmap IncOctober 30, 2025

FDA 483 - Retmap Inc - October 30, 2025

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Record Details

An FDA inspection of Retmap Inc, a manufacturer in Chicago, revealed significant deficiencies across its quality system. Observations included inadequate documentation of equipment maintenance, failure to control nonconforming products, and insufficient supplier management. The firm also lacked proper procedures for corrective and preventive actions, failed to conduct timely management reviews, and did not perform required quality audits.

Company: Retmap Inc
Inspection Date: October 30, 2025
Product Type: Other
Office: Chicago District Office
Person: Jesse A. Vazquez (Medical Device Specialist)

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ID · 58ebb169-777e-4508-bbd9-d0c470f388be