FDA warns Wyeth on notice from FDA for problems at Puerto Rico plant
Seems a Wyeth plant in Puerto Rico that makes several popular medications, has had problems during a recent FDA inspection.
All the complaints had to do with quality control (more precisely, the lack thereof).
FDA warns Wyeth on quality at Puerto Rico plant | Reuters.com
Some of the products mentioned include Advil, Prempo, Caltrate, and Effexor
Here is the FDA warning letter.
The main point appears to be that no corrective actions have ben determined and implemented so the problems do not happen again. Anytime an incident of any type occurs, an investigation is suppose to be initiated and a set of recommendations develop with a focus on preventing this from re-occuring. While this sounds simple, sometimes , it can be more complicated. It is not always possible to determine why something happened, especially if the process is looked at as finding s scapegoat. This leads to situations where the details that may be vital to solving the issue, never emerge for fear of losing a job.
Outsourcing pharma has more details. It seems there was also an unknown substance in the birth control pill Triphasil and that Wyeth has changed their story a couple of times and has issued a voluntary recall of 20 lots of this product from wholesale distributors.
It should be noted that the company states that none of these problems had any impact on patient safety or product efficacy.
It will be interesting to see how quickly Wyeth responds to this warning letter. They had 15 working days (until May 29) to respond in writing and another 15 days to implement a corrective action (until June 20).
Here is a whole list of news articles:
Technorati Tags: drug safety, FDA, Wyeth
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