Failure to Follow Procedures to Prevent Contamination Alleged

Proper drug manufacturing is critical to the safety of the American public.

On August 6, 2015, Mylan Laboratories Limited received a warning letter from the U.S. Food and Drug Administration (FDA.) Mylan is a company which manufactures pharmaceuticals. Many of those products are generic medications. It is the FDA’s job to make certain that medications that will be brought into the United States are manufactured correctly and under the right standards.

What are the Issues?

The basis of that letter is that three of Mylan’s manufacturing facilities were in “significant violations of … good manufacturing practice regulations.” Mylan responded to the original concerns brought to its attention, but according to the letter the FDA did not find its responses satisfactory.  Specifically, the FDA’s concerns include:

• Failure, “to establish and follow appropriate written procedures…designed to prevent microbiological contamination of drug products…”
• Failure “to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure … drug products conform to appropriate standards of identity, strength, quality and purity.”
• Failure “to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed.”

The FDA notes that it has questions of the ability of Mylan’s “current corporate quality system to achieve overall compliance.” It is also concerned that “several violations are recurrent and long-standing.”

What Next?

Mylan is required to resolve the problems noted by the FDA. It notes in its letter that Mylan is “responsible for determining the causes of these violations, for preventing their recurrence, and for preventing other violations.” The FDA notes that it could choose to, “withhold approval of any new applications or supplements” and could also “refuse admission into the United states of articles manufactured at” any of the listed plants. All of the plants are in Bangalore, India. For other actions by the FDA related to Mylan, see the FDA’s website.

How Does This Affect You?

The FDA cares about the proper manufacturing of products because it wants to keep the American public safe from defective manufacturing. If a product is manufactured in a defective fashion and injures someone, the manufacturer might be responsible for any harm it causes. Mylan itself recalled a number of injectable products back in June of this year, “due to visible foreign particulate matter.”  This was a voluntary recall.