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Companies of all sizes are being inspected. To become compliant with GMP guidelines, passed in 2007, dietary supplement companies need to perform analytical testing of their products. Analytical laboratory analysis falls under the category of “manufacture” as defined by FDA CFR. Therefore, if testing is not performed, the dietary supplement company will be considered non-compliant […]
FDA has amended the regulations to expand the scope of clinical investigator disqualification. Under this rulemaking, when the Commissioner of Food and Drugs determines that an investigator is ineligible to receive one kind of test article (drugs, devices or new animal drugs), the investigator also will be ineligible to conduct any clinical investigation that supports […]
ADPEN Laboratories, Inc.
11757 Central Parkway
Jacksonville, FL 32224 USA
Fax: (904) 641-8423