Evolus, Inc.: otulinum toxin Type A

©® DWP-450 commercial DP vials 4 effectively reduces endotoxin by a minimum of 3 logs and provide summary data and the validation teport in the BLA resubmission.

Submit container closure integrity data to support the proposed parameters in the BLA resubmission.

You did not routinely monitor bioburden © to verify continued microbial control of the drug product ©) "Implement routine bioburden monitoring ® In addition, provide a description of the bioburden test method and provide method qualification, summary data, and the qualification report.

The information you provided in the BLA suggests that your DS reference material management program does not generate sufficient quantities of a given reference material lot to support all the required testing.