Medical Device Manufacturer Warning Letters

Medical Device Manufacturer Warning Letters

The Food and Drug Administration (FDA) uses various methods to monitor the safety and efficacy of medical devices.

Some of the feedback FDA receives from products and manufacturers comes from on-site audits and inspections of manufacturing facilities by FDA inspectors.

When a nonconformance is noted during an FDA visit, the responsible branch of the agency will note deficiencies using a Form 483, which is communicated to management at the conclusion of an inspection. If deficiencies are not resolved promptly, or are of a scale that requires a major response, the FDA will follow up with the affected manufacturer(s) through the issuance of warning letters.

The FDA also issues warnings to manufacturers and other responsible parties when they learn of a non-conformance with the Food, Drug and Cosmetics Act, to include invoking punishments and requiring enforcement actions like product recalls and corrections.