FDA Issues Warning to Mylan Over CGMP Violations

Dec 02, 2011   

On November 22, 2011, the U.S. Food and Drug Administration (FDA) published a Warning Letter to Mylan, Inc. Found here, the October 13, 2011 Warning Letter cites Mylan for “significant violations of current good manufacturing practice regulations.” The Warning Letter came as a result of inspections of Mylans Puerto Rico plant, which took place in January and February of 2011. While the Warning Letter came roughly seven months after the inspections uncovered these deficiencies, Mylan was unable to demonstrate to the Agency that it was otherwise compliance with applicable requirements under the law.

FDAs Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals are set forth in 21 C.F.R. part 211. These regulations provide the minimum standards for which manufacturers must follow and cover a range of manufacturing activities, including required personnel, standards for sanitation of buildings and equipment, as well as recordkeeping requirements and laboratory controls. In the present case, Mylan was cited for various CGMP violations, including failure to establish required laboratory controls. In particular, FDA cited the company for failing to test each patch of its drug product to ensure that it conforms to final specifications for the drug product, as provided by 21 C.F.R. § 211.165(a).

While the violations cited in the Warning Letter were observed upon FDA inspections of Mylans plant earlier this year, the Letter was issued only recently after the company failed to demonstrate to the FDA that it has taken all necessary corrective actions. In addition to notifying the particular firm, FDA Warning Letters notify the public that a particular firm has allegedly violated federal law. Thus, given the bad publicity that these letters generate, it is advantageous for firms to correct possible violations even before the FDA issues Warning Letters.

For more information about CGMP requirements or FDA enforcement action please contact us at contact@fidjlaw.com.