Mylan aims to ‘reduce complexity’ at Form 483-hit plant

By Ben Hargreaves

- Last updated on GMT

(Image: XtockImages)
(Image: XtockImages)

Related tags: Mylan, Fda

In a second quarter call with investors, president of Mylan, Rajiv Malik, stated the company has undertaken a restructuring and remediation plan at its Morgantown, West Virginia plant.

The restructure will involve a reduction in the number of products the facility will produce, in order to maintain “the highest quality manufacturing standards”​.

The news comes after the company was hit by a Form 483 that included thirteen observations​ at its plant.

After the US Food and Drug Administration (FDA) noted that that its Quality Unit had not properly validated cleaning processes and that written procedures were not adequately followed, the company stated that it had “committed to a robust improvement plan”​.

The transcript of Malik’s statement notes that these improvements are coming at the cost of a “negative impact on production levels, product supplies, and operations”.

Though he continued to say that “long term these actions will only further strengthen our Morgantown site”.

He noted that the company has submitted a comprehensive response to the FDA addressing the observations that were made during the initial inspection through March 19 to April 12, 2018.

Shortly after the FDA’s inspection, Mylan announced that it was cutting away a large part of its workforce at the plant – a blow to the county​, where the company is one of the largest employers.

The good and the bad

While the Morgantown facility is still working on improving its process, Malik revealed that another of the company’s plants had received positive news – after its Nashik, India-based plant had a previously issued warning letter lifted and was now “operating business as usual”.

The news comes after the site had run into trouble with the FDA over quality control issues​ last year. In particular, the Administration noted that there were repeated issues of missing or inaccurate analytical data observed at the same plant over multiple inspections and therefore delivered a warning letter.

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