FDA Requires Two Harsh Warning Letters for Stryker
 
In March 2007, the United States Food and Drug Administration sent a letter to Stryker Corporation about several practices and conditions seen going on in several of their factories.  Many medical experts believe that, even after receiving a FDA warning letter, Stryker did little or no significant action.
 

One part advise and the other part a wake-up call, the FDA say that several of Stryker’s manufacturing plants are substandard and changes need to be  made. The letter states: “This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act (21 U.S.C. § 351(h)), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation.”
 

Although the letter did have harsh indications, Stryker did little or no activities with regards to the letter, and not much was done until more complaints were filled against Stryker.   The FDA also noticed the amount of complaints rising and gave another warning letter to Stryker, which was much harsher than the first.   In this second letter the FDA warned Stryker if they did not take any action the following repercussions may happen:
 
•   Seizure of company property
•   Levy fines
•   Face injunctions
•   Disapproval on the sale of new Stryker products
•   Notification to other government agencies about these issues so it can be considered when awarding government contracts

 

Those medical experts who were following the situation were in agreement that the FDA’s second letter was as serious as it can get. The second letter received by Stryker was as strict as it can get without actually calling for a recall.
 

Stryker officials say that the FDA re-inspected the plant in 2009 and all issues have been cleared.  "The resolution of the Mahwah, New Jersey warning letter is another important step in demonstrating our firm commitment to significantly transforming our quality systems throughout our organization," says Stephen MacMillan, Stryker's chairman, president and CEO.
 

MacMillan also states that “The investments we have made, and will continue to make, are resulting in solid progress toward our goals.” In addition to the warning letter for its Mahwah facility, Stryker has received warning letters for a Biotech division plant in Massachusetts and for a manufacturing plant in Ireland.   The warning letter for the Biotech plant was lifted as of October 2009.


URL References:
enn.com/top_stories/article/29762
fda.gov/ICECI/EnforcementActions/WarningLetters/2007/ucm076583.htm
 

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