Mylan Receives FDA Form 483 Noting 13 Inspection Observations

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:

• Responsibilities and procedures in the quality control unit not fully followed. The FDA noted that there were numerous instances of “lack of appropriate oversight” by the Quality Unit and chastised senior management for not ensuring compliance with suitability and effectiveness of quality systems.
• Sanitation of equipment to prevent contamination was inadequate. The investigators found that the plant was not following proper protocols to prevent cross-contamination of all manufacturing equipment shared between its 230 oral dosage products. The document included that in the Morgantown Cleaning Validation: 2017 Annual Program Review, 68 swabs taken from certain manufacturing equipment produced “aberrant results.”
• Written procedures were not followed for cleaning and maintenance of equipment. Cleaning checklists failed to document any concerns with equipment.
• Laboratory controls do not include appropriate test procedures that assure drug products adhere to appropriate standards of identity, strength, quality, and purity. Laboratory analyses for failed cleaning verification tests did not consider a thorough assessment of the adequacy of the sanitation procedure.
• Reserve samples from sample lots of drugs were not visually examined annually for evidence of deterioration. The annual inspection of reserve samples is limited to the labeling and container closure system without visually observing the drug product for signs of deterioration.
• Lack of written procedures for production and process controls that ensure the drug products have the proper identity, strength, quality, and purity. Absence of adequate process controls to ensure properly qualified tablet presses and validation parameters for each tablet drug product.

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.”