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 regardless of the reason for not testing.
This new challenge for production will require substantial new testing in order to maintain compliance. Some dietary supplement companies have already found that outsourcing the testing, though thousands of dollars per year, is a more sensible business strategy than investing millions developing and maintaining their own compliant laboratories. When outsourcing analytical testing to laboratories, the FDA requires the outside lab to be cGMP compliant and FDA inspected.