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2016-08-02 Pharmaceuticals - BFS products:

Your chances of passing an FDA (or EMA or other highly regulated country) inspection with the data you have is very close to zero. Sorry.     As I have made BFS PE containers and have been able to attain

2016-08-01 Pharmaceuticals - BFS products:

Dear Misa:    As you have to demonstrate a minimum of Fo = 8, I am not sure that you will have success in registering the product. with an Fo of <3. For this study you need to use pharmacopoeial recognized


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