FDA hits Mexican drugmaker Degasa with warning letter
The FDA issued a warning letter to Mexican finished-pharmaceutical manufacturer Degasa for issues including misbranding, failing to conduct adequate testing and problems with its water system.
In the letter, posted on the agency’s website, the FDA said a September 2017 inspection of Degasa’s Morelos plant found “numerous misbranding issues" and that the facility’s quality unit wasn’t “able to fully exercise its authority and/or responsibilities.”
Products that were found to be mislabeled included: Dynarex Povidone Iodine Prep Solution, Dynarex Povidone Iodine Surgical Scrub Solution, Dukal Povidone Iodine USP 10% Prep Solution, Dukal Antiseptic Sudsing Skin Cleanser Scrub Solution and Medi Choice Scrub Solution Antiseptic Bactericidal Sudsing Skin Cleanser.
The agency is calling on the company to conduct testing within 30 days on all batches to determine their microbial quality, in addition to “an independent, comprehensive assessment of the manufacturing operations used to manufacture each of your topical drug products, with special emphasis on material inputs, enhanced bioburden controls, and contamination prevention.”
Degasa’s water system was also found to be deficient, the agency said, adding that “our findings indicate that your water system was not appropriately designed, controlled, and maintained to consistently produce high-purity water.”
May 1, 2018
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