FDA hits Mexican drugmaker Degasa with warning letter

FDA sign
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.” (FDA)

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.

Free Daily Newsletter

Like this story? Subscribe to FiercePharma!

Biopharma is a fast-growing world where big ideas come along daily. Our subscribers rely on FiercePharma as their must-read source for the latest news, analysis and data on drugs and the companies that make them. Sign up today to get pharma news and updates delivered to your inbox and read on the go.

The company, which was founded in 1959, focuses on wound care and medical products, according to its website.

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.”

Read more on

Suggested Articles

Pfizer says two lots of migraine med Relpax failed to meet microbial standards and may be contaminated with genera pseudomonas and burkholderia.

Emcure has had its share of run-ins with the FDA in the past over the sterility of its plants. Now, it can notch one more black mark on its belt.

The FDA has slapped a warning letter on an Indian solvent recycler that may have contributed to the contamination of blood pressure meds.