Every week some unfortunate company in the US receives a warning letter from the FDA for not having or not following procedures. Today I picked up this report, which is all too common. The lesson: have procedures, follow them!!
Warning: Devicemaker Can't Prove It Reviewed Sterility Results
Connecticut-based devicemaker Gaven Medical has received an FDA warning letter for manufacturing violations related to its Punctur-Guard winged sets for blood collection. The FDA maintains there is no documentation showing the company reviewed sterility results for one lot of the device prior to its distribution, according to the June 26 letter recently posted to its website. The letter stems from an inspection conducted April 27 through May 8.
The GMP Letter
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