Adverse events noted in 483 for Purdue Pharma.

Purdue Pharma Purdue Pharma L.P., is privately-held pharmaceutical company founded by physicians. It is located in Stamford, Connecticut.

Purdue is best known for painkillers, but they have also branched into other areas such as oncology and nutraceuticals. , Stamford Stamford, town, England
Stamford, town (1991 pop. 18,127), in the Parts of Kesteven, Lincolnshire, E central England, on the Welland River. It is a market town. Products include diesel engines, electrical equipment, bricks, and tiles. , CT, Stoneham Stoneham (stōn`əm), town (1990 pop. 22,203), Middlesex co., NE Mass., a chiefly residential suburb of Boston; settled 1645, set off from Charlestown and inc. 1725. The Stone Zoo is there. , MA, District

Purdue Pharma, Stamford, CT, received a two item 483 because it did not report adverse drug experiences (ADEs) to the agency, according to according to
prep.
1. As stated or indicated by; on the authority of: according to historians.

2. In keeping with: according to instructions.

3. a re port prepared by investigator Mark McClain from the Stoneham, MA, District Office.

"Not all adverse drug experiences that are both serious and unexpected have been reported to FDA FDA
abbr.
Food and Drug Administration

FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration. within 15 calendar days of initial receipt of the information," FDA stated.

For example, approximately 10% of all expedited reports of adverse drug experiences that are both serious and unexpected were submitted late for the year 2006 due to various reasons.

Also, not all adverse drug experience information was reported to FDA, the report continued.

Specifically, some reports reviewed that were submitted to the agency via MedWatch had all names of the reporter identified only as "withheld."

Purdue declined to comment for this story. Purdue Pharma, Stamford, CT, 7/18-25/06, Doc. 109959M, $5 plus retrieval.

COPYRIGHT 2007 Washington Information Source, Inc.
No portion of this article can be reproduced without the express written permission from the copyright holder.

Reader Opinion

Article Details
Printer friendly Cite/link Email Feedback
Title Annotation:	HUMAN DRUGS
Publication:	Inspection Monitor
Date:	Jul 1, 2007
Words:	156
Previous Article:	API firm written up for qualification, calibration and maintenance of equipment.
Next Article:	Berkline cited for quality policy flaws in 12-item FDA write-up.
Topics:	Pharmaceutical industry

Related Articles
Forms replace notebooks at Purdue Pharma labs.
FDA says no to visual exam for particulates; Purdue recalls 388 lots of oxycontin.
Purdue improves e-record tracking of Oxycontin adverse events after audit. (Human drugs).
Inspection log.
483 citations for environmental monitoring down; not even in top 30.
QA failures including OOS trip up DSM Pharma.
Adverse events noted in 483 for Purdue Pharma.
Failure to report adverse events noted in 483 for Purdue Pharma.
GlaxoSmithKline.
Millennium Pharma cited in 3-item 483 for not reporting ADEs: Millennium Pharmaceuticals, Cambridge, MA, Stoneham, MA, District.