Story display


ID:

713

Date:

2011-11-23

Headline:

‘Significant’ offenses cited at Mylan plant

Reporter's name:

Patricia Sabatini and Len Boselovic

Delay/denial:

No

Lawsuit:

No

Fees:

No

Media outlet:

Pittsburgh Post-Gazette

City:

Pittsburgh, PA

Summary:

The Food and Drug Administration (FDA) warned a Pennsylvania pharmaceutical company that its Puerto Rico generic-drug plant had committed “significant violations” of manufacturing regulations as part of a 2011 inspection – for the third year in a row. The FDA released the first two inspection reports, from 2009 and 2010, under the Freedom of Information Act.

Notes:

The FDA refused to provide a copy of the 2011 inspection report without a FOIA request.

Keywords:

Mylan, pharmaceutical plant, drug manufacturer, Food and Drug Administration, FDA, generic drug, warning letter, inspection, laboratory, loperamide hydrochloride, inspection reports, Form 483

URL:

http://www.post-gazette.com/pg/11327/1191924-28.stm


Agencies:

FDA

States:

NC
PA
PR

Categories:

drug safety
health care


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