PharmaEssentia Corporation: P1101

March 13, 2020, under section 351(a) of the Public Health Service Act for P1101.

Based on the results of the human factors (HF) validation study data, root cause analysis, and participants' subjective feedback, the proposed product design and user interface do not support safe and effective use of the product, as previously communicated to you in our October 15, 2020, correspondence regarding our review of your HF study results report.

February 26, 2021, prior to commencing your HF validation study, consider additional design modifications and labeling changes, and submit the results of another HF validation study to demonstrate that the product can be used safely and effectively.

PharmaEssentia Corporation, FE] 3005182038, Taipei, Taiwan are required before this application can be approved.

FDA must assess the ability of these facilities to conduct the listed manufacturing operations in compliance with CGMP.

You may respond to deficiencies in this Complete Response Letter while the travel restrictions remain in effect.

However, even if these deficiencies are addressed, the application cannot be approved until the required FDA inspections are conducted and any findings are assessed with regard to your application.

Therefore, provide sterility test method suitability results from two additional batches of P1101, 500 mcg/mL tested at PharmaEssentia Corporation.