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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.
The FDA sent warning letters to five firms for compounding topical anesthetic creams, but the firms say their manufacturing practices are beyond the FDA’s jurisdiction.
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.
Bausch & Lomb’s MoistureLoc contact lens solution was cited as “adulterated” in a recent FDA warning letter, which followed an agency inspection that found the firm did not conform to GMP requirements. Read More
Natren received an FDA warning letter for misleading information on its website and the labeling for its products Gy-Na-Tren Vaginal Health Solution and Life Start.
The FDA sent warning letters to five firms for compounding topical anesthetic creams, but the firms say their manufacturing practices are beyond the FDA’s jurisdiction. Read More