IMB

Irish Medicines Board confirms recall of anti-depressant drug manufactured by GSK

Posted by Gordon on April 7, 2014

Posted in: cGMP & QC. Tagged: 483 warning letter, GSK, HPRA, IMB, Recall. Leave a Comment

According to RTE News

The Irish Medicines Board has confirmed that a number of batches of an anti-depressant drug being recalled by GlaxoSmithKline had been placed on the Irish market. The recall was ordered following a warning from the US Food and Drug Administration. It said the active ingredient for the drug, manufactured in Co Cork, may have been contaminated with a solvent from a pharmaceutical waste tank.

The FDA issued a warning letter on March 18th which can be found here:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm390435.htm

It states the following (please note, the (b)(4) code is a redacted version of the actual product code):

Your firm discovered that the (b)(4) used to manufacture (b)(4) batches of (b)(4) and (b)(4) batches of (b)(4)was contaminated with material from your pharmaceutical waste tank, which contained APIs, intermediates, and solvents. Examples of chemicals that are collected in the waste tank include (b)(4). Your firm became aware of this contamination in January 2012 and completed risk assessments to determine the impact on the quality of (b)(4) manufactured using the contaminated solvents on April 19, 2013. Your firm distributed (b)(4)shipments of (b)(4) potentially contaminated (b)(4) batches after becoming aware of this significant deviation. In contrast, (b)(4) batches made with the contaminated (b)(4) were rejected.

FDA and IMB (HPRA) product recall examples

Posted by Gordon on November 13, 2013

Posted in: GMP & Quality Assurance. Tagged: FDA, HPRA, IMB, Product Recall. Leave a Comment

Below are links to actual product recalls by regulatory authorities illustrating the contents of a recall document.

FDA Recall Example

IMB Recall Example

New name for IMB from Jan 1st 2014

Posted by Gordon on September 30, 2013

Posted in: GMP & Quality Assurance. Tagged: HPRA, IMB, Name. 1 comment

From January 1st 2014 the Irish Medicines Board (IMB) will be known as the Health Products Regulatory Authority (HPRA).

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