Drugmaker Humco Lands Warning Letter Over GMP Deficiencies, Unapproved Drugs

March 17, 2017

The FDA delivered a warning letter to Humco for deviating from GMP standards and manufacturing unapproved and misbranded drugs.

The company’s facility in Texarkana, Texas lacked validated manufacturing procedures for several drug products, according to an FDA inspection from June 25 to July 1, 2015. Other GMP deviations included failing to validate the facility’s purified water system and neglecting to thoroughly investigate batch failures. The FDA said some of these are longstanding problems.

For at least three years, the facility manufactured drugs using an unauthenticated purified water system, and since 2012, it failed to validate manufacturing processes, the warning letter said.

FDA investigators deemed several of the firm’s drug unapproved and misbranded as well, citing the drugs’ labels and intended use.

For example, Humco’s Cherry Flavored Potassium Chloride Oral Solution failed to include sufficient directions on its label for an average person to use the drug. The agency also deemed the oral solution unapproved, because there is no FDA-approved application on file for the drug.

The FDA declared other products misbranded, because their labels did not communicate critical safety information or include the “Rx only” symbol. 

Humco did not respond to a request for comment.

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