Mylan site receives US FDA 483, commits to ‘robust improvement plan’

By Flora Southey contact

- Last updated on GMT

Getty/bankrx
Getty/bankrx
Shared manufacturing equipment and utensils used between non-potent and potent drugs were among the cleaning concerns observed by the US FDA in West Virginia, US.

The US Food and Drug Administration (FDA) has issued Mylan Pharmaceuticals Inc. a Form 483​ with thirteen observations following an inspection at its facility in Morgantown, West Virginia.

Between March 19 and April 12, 2018, FDA inspectors observed “numerous instances of a lack of appropriate oversight” ​by Mylan’s Quality Unit, including inadequate cleaning processes.

“Your Quality Unit (QU) failed to adequately validate the cleaning processes of all manufacturing equipment and utensils shared between your 230 oral dosage drug products – potent and non-potent – to ensure no cross-contamination of active ingredients and detergent occur between products,” ​said the FDA.

“Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product,”​ the Agency continued.

Mylan has submitted a response to the FDA and “committed to a robust improvement plan,” ​said the firm in a statement​.

“We remain confident in the quality, safety and efficacy of our drug products, including those in distribution, and we continue to manufacture and ship product from the site.

“Mylan will continue to maintain a close dialogue with the Agency and is fully committed to working with FDA to address its observations,” ​it added.

Job cuts

In April this year, Mylan announced plans to layoff approximately 15% of its workforce in Morgantown, primarily in operations.

“As the industry has changed and regulatory expectations have continued to evolve, we’ve realized that our Morgantown plant needed to be right-sized to be less complex,”​ a Mylan spokesperson told us. 

“The right-sizing is consistent with discussions we are having with the FDA and is necessary in order to position the site as best we can for continued operations,”​ the spokesperson added.

Related topics: Regulatory & Safety, Regulations

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