US FDA warns Mexican OTC maker: Misbranded drugs, lost data, unsuitable water
The US Food and Drug Administration (FDA) released the warning letter this week – issued April 18, 2018 – following a site inspection at Degasa’s facility in Morelos, September 4-18, 2017.
According to the letter, the company failed to implement adequate microbial testing for its over-the-counter (OTC) drug products.
“You lacked testing of these products for microbial attributes, including absence of objectionable microbial contamination, or sterility, where appropriate,” said the FDA.
A third-party assessment of Degasa’s manufacturing operations for its topical drug products has been requested by the Agency.
The FDA also flagged the firm’s laboratory records, saying they lacked complete data.
“According to your employee, half the data you generated over a year was lost,” said the Agency.
The FDA was also concerned by Degasa’s water system, which it said was not suitable for its intended use.
“Water is a major ingredient in your drug products. It is essential that you employ a water system that is robustly designed, and that you effectively control, maintain, and monitor the system to ensure it consistently produces water suitable for pharmaceutical use that conforms to the USP monograph for purified water and appropriate microbial standards,” the FDA said.
Misbranded drugs – included Dukal Antiseptic Sudsing Skin Cleanser Scrub Solution and Medi Choice Skin Cleanser, which fail to include drug names in their "statements of identity" – were also of primary concern.
The FDA has recommended Degasa consult with a qualified expert to assist in meeting GMP requirements.
