Drugmaker Humco Lands Warning Letter Over GMP Deficiencies, Unapproved Drugs

February 27, 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.

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