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Nassif Associates received a recent FDA warning letter for current good manufacturing practice violations regarding the company’s cardio-card interpretation systems.
Skytron violated cGMPs and lacked adequate standards for complaint reviews, making its surgical beds adulterated and misbranded, an FDA warning letter said.
Dupaco violated cGMPs by not performing required tests or following complaint procedures on its blood/fluid warming sets, according to an FDA warning letter.
Rhein 83 must stop marketing its dental products in the U.S. because it lacks an approved premarket approval (PMA) application, an FDA warning letter said.
Trionix Research Laboratory neglected to perform device change procedures on a faulty product and did not inform the FDA of the malfunction, a recent agency warning letter said.
Dupaco violated current good manufacturing practices by not performing required tests or following complaint procedures with its blood/fluid warming sets, according to an FDA warning letter.
Information on GSCM Ventures’ website, including the name of a product it sells, wrongly promotes it as a treatment for obesity, an FDA warning letter said.
The FDA warned two firms for compounding drugs that it said are “essentially copies” of commercially available, approved products without any documented reason.