FDA issues warning letter to Mylan after inspections
Federal drug safety inspectors found "significant violations" at a Mylan Inc. manufacturing plant in Puerto Rico during inspections early this year, the Food and Drug Administration said.
The FDA sent what it calls a warning letter to Mylan CEO Robert Coury in October telling him that Mylan's initial response to the violations was insufficient. The letter, the first Mylan ever received, had to do with the plant failing to maintain and test for uniformity in some drugs it produces at the plant in Caguas, Puerto Rico.
"You should take prompt action to correct the violations detailed in this letter," the FDA's warning letter states. "Failure to promptly correct these violations may result in legal action without further notice."
Canonsburg-based Mylan, the world's third largest generic drug maker, is working with the FDA to address the problems at the plant and expects to "resolve this matter expeditiously," spokeswoman Nina Devlin said.
"Production and shipment of product from the Caguas facility continues uninterrupted," she said.
Analysts who follow Mylan said investors should not be too concerned with the letter.
"It only took 50 years, but FDA finally found something apparently worth issuing a warning letter to Mylan," Elliot Wilbur, analyst with New York-based Needham & Co., said in a research note.
Other than Mylan getting its first warning letter in history, Wilbur said it's "a nonevent" because the plant's production in not affected and the plant is not tied to any of Mylan's major product introductions coming in the next two years.
"While Mylan indicated that it takes the warning letter for the Caguas, Puerto Rico facility seriously, it is immaterial in terms of manufacturing capacity," said analyst David Buck, of Buckingham Research Group Inc., New York.
Mylan stock traded at $17.69 this afternoon, down 20 cents on the New York Stock Exchange.
Add Alex Nixon to your Google+ circles.
Show commenting policy
TribLive commenting policy
You are solely responsible for your comments and by using TribLive.com you agree to our Terms of Service.
We moderate comments. Our goal is to provide substantive commentary for a general readership. By screening submissions, we provide a space where readers can share intelligent and informed commentary that enhances the quality of our news and information.
While most comments will be posted if they are on-topic and not abusive, moderating decisions are subjective. We will make them as carefully and consistently as we can. Because of the volume of reader comments, we cannot review individual moderation decisions with readers.
We value thoughtful comments representing a range of views that make their point quickly and politely. We make an effort to protect discussions from repeated comments either by the same reader or different readers.
We follow the same standards for taste as the daily newspaper. A few things we won't tolerate: personal attacks, obscenity, vulgarity, profanity (including expletives and letters followed by dashes), commercial promotion, impersonations, incoherence, proselytizing and SHOUTING. Don't include URLs to Web sites.
We do not edit comments. They are either approved or deleted. We reserve the right to edit a comment that is quoted or excerpted in an article. In this case, we may fix spelling and punctuation.
We welcome strong opinions and criticism of our work, but we don't want comments to become bogged down with discussions of our policies and we will moderate accordingly.
We appreciate it when readers and people quoted in articles or blog posts point out errors of fact or emphasis and will investigate all assertions. But these suggestions should be sent via e-mail. To avoid distracting other readers, we won't publish comments that suggest a correction. Instead, corrections will be made in a blog post or in an article.
- Founder of Z&M Cycle Sales in Hempfield killed in Florida motorcycle crash
- Wilkinsburg mom pleads guilty to child endangerment, will testify against boyfriend
- Baseball America names Pirates as organization of the year
- Steelers notebook: Seahawks’ Sherman gets better of WR Brown
- Kane to announce plans for next chapter in porn email saga
- LCB offers free holiday shipping to state stores
- Steelers stalled by Seahawks, on outside of AFC wild-card picture
- Sports Deli is latest tenant to say goodbye to Parkway Center Mall
- Rossi: It’s past time for NFL to protect players
- Steelers players say they support Tomlin’s attempts at deception
- New Florence man charged with killing police officer