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Self-Designated Responsible Person: How a Two-Person Foreign Manufacturer Completed MoCRA Without an Agent

May 01, 2026

2026-05

Complete Elixir registered its Canadian facility and 28 SKUs in May 2026

The sequence was U.S. entity registration, FDA facility registration for the company's Canadian plant, confirmation, then product listing - completed May 2026.

The company reports the FDA-facing steps were straightforward and that U.S. entity formation was the schedule-critical item, since the Responsible Person designation depends on it.

Keeping the role in-house leaves safety substantiation and adverse-event reporting with the formulator rather than an agent.

The Responsible Person is accountable for safety substantiation and adverse event reporting. I formulate the products, so handing that role to a third party did not make sense to me.

Clara Song, Founder and Formulator, Complete Elixir

About Complete Elixir

Complete Elixir is an independent professional skincare company based in Surrey, British Columbia. Founder and formulator Clara Song began research and development in 2020 and incorporated Complete Elixir Skincare Inc. in June 2024. The company develops and manufactures its full line at its own 941-square-foot formulation facility, which became fully operational in April 2026, using small-batch multi-cycle production rather than contract manufacturing. Complete Elixir specializes in complicated skin - acne-prone, sensitive and barrier-compromised skin - and pairs its products with professional education for estheticians. The company supplies the United States through a California distributor and is expanding into Korea, China and Israel. Learn more at completeelixir.com.