FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Mylan Draws 483 for Cleaning and Maintenance, Quality Control Issues

July 3, 2018
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A heavily staffed FDA inspection of pharmaceutical giant Mylan’s manufacturing facility in Morgantown, West Virginia netted the company a lengthy Form 483 listing numerous deficiencies in the firm’s quality control unit.

The inspection was handled by a team of eight agency officials, including four investigators. The 483 included 13 observations ranging from inadequate process controls to failure to review changes to written procedures.

The investigators found that the firm’s quality unit sometimes failed to properly oversee certain tasks. The unit was not always involved in approving change controls for products and it did not adequately conduct reviews and approvals of equipment used in manufacturing, packaging, labeling and holding drug products.

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