Code of Federal Regulations Title 9. Animals and Animal Products § 9.113.6 Animal and Plant Health Inspection Service testing

(a) The Administrator is authorized to cause a biological product, manufactured in the United States or imported into the United States, to be examined and tested for purity, safety, potency, or efficacy;  in which case, the licensee or permittee shall withhold such product from the market until a determination has been made.

(b) The final results of each test conducted by the licensee and Animal and Plant Health Inspection Service shall be considered in evaluating a biological product. A serial or subserial which has been found unsatisfactory by a required test prescribed in a filed Outline of Production or Standard Requirement is not in compliance with the regulations and shall not be released for market.