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FDA "Approved" Lab vs FDA "Registered" Lab
Location: BlogsAnalysis and Product Quality    
Posted by: jhildreth 3/25/2007 4:30 PM
Beware of any contract lab claiming they are a FDA "Approved" or "Certified" Lab. Contrary to what advertisements claim, FDA does not approve or certify labs. This is not to be confused with a lab claiming to be FDA "Registered" which actually does exist. Any lab can register with the FDA without passing any initial inspection or having any particular certification. The registration is for drug testing only and in no way implies the lab is qualified or has the expertise to test dietary supplements.
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Comments (2)  
Re: FDA "Approved" Lab vs FDA "Registered" Lab    By mroman123 on 3/27/2007 3:59 PM
There is similar confusion regarding ISO17025 "certification" (or actually accreditation) and ISO17025 compliance. A lab can be ISO 17025 compliant, which means it follows the ISO guidelines. It will have to have the appropriate SOPs in place, and follow those SOPs. An ISO 17025 accredited lab, however, has been audited by an independant organization such as A2LA. ISO accreditation is on a per method basis; therefore, a lab can be accredited for some methods and not for others. Labs can be ISO 17025 compliant without being accredited, but not vice versa.
Re: FDA "Approved" Lab vs FDA "Registered" Lab    By jamesnealk on 4/9/2007 1:50 PM
This is a very important issue. A company can be ISO 17025 approved for one test but not even be doing that test. Then they say that they are an ISO lab but it has no relevance to the work they do in the DS industry. A company can be FDA registered which does mean that they open their lab to FDA audits but it does not mean that FDA has approved them or that any inspection that they have is releavant to the testing that they for dietary supplements.
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