Adello Biologics, LLC: BLA 761082

Furthermore, it appears there might be errors in the data shown in table 28. In your 351(k) BLA resubmission, provide:

19. In your response to our IR dated February 12, 2018, you explain that visual inspection is performed on all Theragrastim DP vials and syringes manufactured in a lot.

Explain how you plan to compare protein assay results at release with stability results when using methods with different read outs, and provide information and scientific justification in your 351(k) BLA resubmission to support the use of the two different protein concentration methods for release and stability testing.

Theragrastim DP packaged in vials and syringes and the results for those studies were submitted in your 351(k) BLA submission.

You did not provide information to demonstrate that the levels of @ detected in these studies do not impact product quality and stability of the drug product stored at long-term conditions up to the proposed expiry date.

However, report CMO-0039 could not be located in your 351 (k) BLA submission.

41. Overall, Module 3 of your original 351(k) BLA submission is not well prepared.

Implement bioburden-reduction filtration Oo and include this information in the BLA resubmission.

63. Provide summary shipping validation report to support shipping of the drug substance to the drug product manufacturing facility.

65. Implement an in-process endotoxin monitoring test with an appropriate limit prior to sterile filtration and provide the information in the BLA resubmission.

Submit draft carton and container labeling that are identical to the carton and immediate container labels submitted on February 28, 2018.

If you do not take one of these actions, we may consider your lack of response a request to withdraw the application under 21 CFR 601.3(c).