The FDA Says You Are Responsible

. . . But do you know who you are?

By: E. Morrey

Cook Pharmica

An FDA Warning Letter was recently issued to a contract testing lab that contained a clear warning indeed: in Warning Letter No. 12-NWJ-12, dated February 17, 2012, to Biochem Laboratories, Inc, the Director of the New Jersey District wrote the following: “In your response, you state that you have informed your clients on the importance of validating the methods, but they have chosen not to validate the methods. In addition, you state that you will inform them again in writing. Your response, ...

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