7. Describe why regulatory agencies would visit a biomanufacturing facility and what their objectives might include. 8. The FDA regulates only the manufacturing of biopharmaceuticals and has no jurisdiction over the marketing of the drugs. a. True or b. False? 9. A change has recently been made with the acquisition of a new and larger fermentation tank. What type of inspection would one expect to receive from the Boards of Health? a. preapproval inspection b. routine inspection c. For Cause inspection d. no inspection required 10. A company receives a customer complaint for a product that was missing 5 tablets in a bottle of 10 tablets. What must the company's reaction be to the complaint? a. investigation b. recall c. send a notice to the FDA d. no action required e. hide the fact