FDAnews Drug Daily Bulletin

WHO Says Indian Mylan Facility Resolved Quality, Data Integrity Problems

June 9, 2017

The World Health Organization said it is satisfied that Mylan resolved the quality issues at its facility in Nashik, India, including out-of-specification results relating to WHO prequalified products.

The FDA issued a warning letter to the facility in April after an inspection discovered numerous quality control and data integrity violations.

The warning prompted fears at WHO that the quality problems could interrupt supplies of antiretroviral drugs used to treat HIV, sold through the WHO Prequalification of Medicines Program.

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