Last week, the FDA issued a 32-page Form 483 to Mylan after a 5-week inspection of its manufacturing plant in Morgantown, West Virginia. The FDA cited 13 inspection observations, including failure to follow proper quality control protocols, lack of adequate cleaning of utensils and equipment, and ineffective laboratory controls and sampling, among others.
Last week, the FDA issued a 32-page Form 483 to Mylan after a 5-week inspection of its manufacturing plant in Morgantown, West Virginia. The FDA cited 13 inspection observations, including failure to follow proper quality control protocols, lack of adequate cleaning of utensils and equipment, and ineffective laboratory controls and sampling, among others.
In April, a Mylan spokesperson had said that it would be laying off 500 employees of the Morgantown plant in an effort to be “consistent with the discussions we are having with the FDA.” A majority of the jobs cut were reportedly in the operations department of the plant.
The heavily redacted form included the following observations, and more:
After the FDA made the form public, Mylan issued a statement that it is “committed to maintaining the highest quality manufacturing standards at its facilities around the world… The company has submitted a comprehensive response to the Agency and committed to a robust improvement plan. 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 [the] FDA to address its observations.”
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