Nov. 12, 2019
The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Mylan’s API manufacturer, Mylan Laboratories Limited Unit 8, on November 5, 2019. The concerns cited by the agency were based on an inspection conducted from May 27, 2019, to June 5, 2019, which placed a primary focus on the manufacturing of Valsartan API. We have been working closely with the FDA as well as other global health authorities to investigate all potential risk associated with the ongoing inquiries related to the nitrosamines impurities and always with patient safety as our primary focus.
Mylan will be providing a thorough response to the Agency which will detail existing controls in place at the facility to mitigate any perceived risk of product contamination and provide additional enhancements as requested. Mylan’s response will be submitted within the required time period of 15 working days.
Of note, extensive testing of APIs manufactured and distributed by the site was performed for the presence of nitrosamine impurities and none were detected. Additionally, an extensive cleaning process and cleaning validation program is in place which is designed to ensure that all the equipment used for manufacturing is cleaned to pre-defined acceptable levels.
No interruption in manufacturing or distribution is anticipated at Mylan Laboratories Limited, Unit 8, based on the aforementioned FDA Warning Letter. No significant commercial impact is expected and no significant launches are planned for Unit 8 in 2020.