Home » FDA Warns Two Manufacturers of Drug Abuse Test Kits
FDA Warns Two Manufacturers of Drug Abuse Test Kits
Two makers of drug abuse test kits have received FDA warning letters — one for good manufacturing practice (GMP) problems and the other for PMA violations. Medical & Clinical Consortium (MCC) was cited for failure to document the validation activities of its manufacturing equipment and other GMP violations. The FDA also sent a warning letter to Omega Laboratories for marketing OTC hair test sample collection systems for drug abuse testing without marketing clearance.
Devices & Diagnostics Letter
Devices & Diagnostics Letter
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