Mylan Andhra plant gets USFDA warning over Valsartan manufacturing violations

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.

New Delhi: The U.S. Food and Drug Administration (FDA) issued a warning letter to drug maker Mylan for “significant deviations” from good manufacturing practices for its manufacturing facility Unit-8 at G. Chodavaram Village, Vizianagaram, Andhra Pradesh, India.

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 said in a statement.

The USFDA warning letter summarized significant deviations from current good manufacturing practise (CGMP) for active pharmaceutical ingredients (API).

During the USFDA inspection, investigators observed specific deviations including, but not limited to, the following:-

• Failure to have adequate written procedures for the receipt, identification, testing and handling of raw materials.


• Failure to clean equipment and utensils to prevent contamination or carry-over of a material that would alter the quality of the API beyond the official or other established specifications.

In a statement, Mylan said that it 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," Mylan added.

The company further apprised that 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.