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Precision Interconnect was hit with a Form 483 for poor corrective and preventive action (CAPA) procedures and failing to ensure that products conformed to requirements. Read More
The FDA issued a final order reclassifying specialized surgical instrumentation for use with urogynecologic surgical mesh from Class I to Class II. The agency requires special controls and testing to show the devices meet all design specifications and performance requirements. Read More
The FDA Florida district office issued a Form 483 to Audifon-USA over inadequate procedures for complaint reviews, corrective and preventive actions, and equipment calibration. Read More
White Square Chemical failed to establish a design history file, complete a risk analysis, and committed other violations, according to investigators who handed the company a Form 483. Read More
The FDA finalized guidance on GMP requirements for combination product manufacturers, adding scenarios to clarify how to comply with certain device requirements. Read More
In a move that could simplify compliance for devices at risk from cyber threats, the FDA said it will evaluate risk based on the potential for patient harm rather than on clinical performance. Read More
Acumedia Manufacturers was cited in a Form 483 for inadequate corrective and preventive action (CAPA) procedures, failing to report a correction or removal, and other violations. Read More
The China Food and Drug Administration (CFDA) has issued new guidance on quality control, finished product inspection, and other procedures for medical devices. Read More