FDA Threatens Device Importer with Seizure, Civil Penalties for CGMP & MDR Violations
The Food and Drug Administration sent a warning letter to medical device importer Primus Medical on Oct. 10, alleging an inadequate response to an inspection that revealed deviations from Current Good Manufacturing Practices (CGMP) regulations and failure or refusal to furnish information required by Medical Device Reporting regulations.
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FDA alleged that Primus, which imports AC-powered hospital beds, violated CGMP regulations by (1) failing to confirm that its suppliers, contractors, and consultants meet specified requirements; (2) not verifying design of the products; and (3) not implementing corrective action procedures. Primus also failed to adequately evaluate complaints, as required by Medical Device Reporting Regulations, FDA said.
FDA threatened seizure of merchandise, injunction, and civil penalties if Primus fails to correct the alleged violations.