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'Significant' Offenses Cited at Mylan Plant

[Pittsburgh Post-Gazette (PA)]

Published Date: November 23, 2011 04:34:00 AM EST
Author: By Patricia Sabatini and Len Boselovic, Pittsburgh Post-Gazette

Nov. 23--The U.S. Food and Drug Administration cited Cecil-based Mylan Inc. for "significant violations" of manufacturing regulations at its generic drug plant in Puerto Rico, according to a warning letter released by the agency Tuesday.

The letter, sent to Mylan Chairman and CEO Robert Coury, was issued Oct. 13 after an inspection at the plant conducted in January and February.

During the inspection, "we identified significant violations of current good manufacturing practice regulations," the warning letter stated.

Mylan responded to the findings in March, but the response lacked "sufficient corrective actions," the FDA letter said.

The FDA told Mr. Coury that Mylan did not have appropriate laboratory procedures for determining whether "each batch of drug product" met specifications.

The letter mentioned one drug, loperamide hydrochloride, an anti-diarrhea medication.

The agency also said the drugmaker did not thoroughly investigate "the failure of a batch or any of its components to meet its specifications."

A copy of the January-February inspection report would only be made available publicly through a Freedom of Information Act request, an FDA spokeswoman said Tuesday. Mylan declined a request Tuesday to provide the inspection report.

The company issued a statement saying it intends to work closely with the FDA "to fully address the observations in the agency's letter and believe we will be able to resolve this matter expeditiously."

Production and shipments from the plant continue "uninterrupted," the statement said.

If Mylan does not correct the violations, it could face legal action, including an injunction and the seizure of medications, the FDA's warning letter said.

The agency also could withhold drug approvals.

The FDA's website indicates the agency has issued 579 warning letters this year to companies worldwide that manufacture drugs, food, medical devices, tobacco or other products it regulates.

Mylan's Puerto Rico plant is located in Caguas, about 20 miles south of San Juan. Medications made there are shipped to Mylan's distribution center in Greensboro, N.C., according to FDA inspection reports.

Previous inspection reports for Mylan's Puerto Rico plant, obtained through Freedom of Information Act requests, show inspectors also cited the facility in 2010 and 2009.

Inspections in both of those years resulted in Mylan receiving a Form 483, which is issued when regulators believe they have found significant violations.

Those inspections did not result in any warning letters.

The FDA can issue a warning letter if the agency is not satisfied with a company's plans to correct problems or if a company fails to make promised fixes.

To view the FDA's Oct. 13 warning letter issued to Mylan, visit

Patricia Sabatini: or 412-263-3066. Len Boselovic: or 412-263-1941.


(c)2011 the Pittsburgh Post-Gazette


Posted: November 2011