FDA Threatens Device Importer with Seizure, Civil Penalties
The Food and Drug Administration threatened device importer and distributor Prime Herbs Corp. with seizure, injunction, and civil monetary penalties for a host of violations that caused FDA to declare the company’s infrared heating lamp adulterated and misbranded. The warning…
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letter, dated Dec. 10, alleges violations of current good manufacturing practice regulations, Medical Device Reporting violations, unapproved marketing, and failure to provide adequate directions for use. FDA said the violations could also affect the awarding of government contracts, as well as premarket approval for related products.