MORGANTOWN — Mylan’s Morgantown plant recently underwent a U.S. Food and Drug Administration (FDA) inspection that led to a report listing conditions that may constitute violations of the Food Drug & Cosmetic Act and related acts.

Mylan issued a statement Thursday June 28 saying it submitted a “comprehensive response and robust improvement plan” to the FDA.

“Mylan is committed to maintaining the highest quality manufacturing standards at its facilities around the world,” it said in its 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.”

The FDA inspection occurred March 19 through April 12.

The FDA listed 13 observations, with explanatory details, in a 32-page Form 483 it presented to Mylan.

The FDA explains that the Form 483 notifies management of objectionable conditions, which it discusses with management. Companies are then encouraged to respond in writing with a corrective action plan.

The FDA points out that a Form 483 is not a final determination of violations. It considers the form along with other factors to determine if further action is needed.

Among the observations:

  • Quality control responsibilities and procedures are not followed.
  • Equipment and utensils are not cleaned or sanitized at appropriate intervals.
  • Written procedures for cleaning equipment and utensils are not followed.
  • Laboratory controls do not include sound, appropriate test procedures to assure drugs conform to appropriate standards of identity, strength, quality and purity.
  • Reserve, representative samples of drug products are not examined visually at least once a year for evidence of deterioration.
  • Changes to written procedures are not appropriately drafted, reviewed and approved by the appropriate people.
  • Drug product production and control records are not appropriately reviewed before a batch is released.

Story by David Beard

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