Arkansas Drug Manufacturer Draws FDA Warning Letter
Dunagin Pharmaceuticals of Rogers, Ark., received an FDA warning letter for manufacturing drugs on the same equipment used to manufacture non-drug products and failing to test samples of product components for its pharmaceutical and nonpharmaceutical dental care products, among other lapses.
The company, which does business under the name Massco Dental, must either discontinue manufacturing drugs on shared equipment or provide a plan showing how it will separate the areas in which it will “maintain dedicated manufacturing equipment for your pharmaceutical manufacturing and nonpharmaceutical product manufacturing operations,” the letter says.
The company also relied on suppliers’ certificates of analysis for incoming components “without establishing the reliability of [the] suppliers’ test results,” the agency said.
March 24, 2023