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A Two-Person Canadian Manufacturer Became Its Own MoCRA Responsible Person - and Says the FDA Part Was the Easy Part

May 01, 2026

2026-05

Complete Elixir registered its Canadian facility and 28 products in May 2026; forming the U.S. entity took longer than the filings

The company's sequence was: register a U.S. entity, register the manufacturing facility with the FDA, wait for confirmation, then list products. The facility registered is the company's own plant in Surrey, British Columbia; the U.S. entity is registered in Washington State.

Founder Clara Song reports that the FDA-facing steps were not the difficult part. Establishing the U.S. corporate entity took the longest by a wide margin - a sequencing detail that matters, because the entity has to exist before the Responsible Person designation can be made.

She has a basis for comparison: the company cleared Korean cosmetics import registration the month before, a four-month process that required apostilled credentials, five notarizations and a Certificate of Free Sale that no Canadian government body issues. Against that, she describes the U.S. filings as straightforward.

Acting as its own Responsible Person keeps adverse-event reporting, safety substantiation and labelling accountability inside the company rather than with an agent. Complete Elixir manufactures its full line in batches capped at 100 litres and now supplies a California distributor serving Los Angeles-area spas and esthetic clinics. The company has grown from two employees at the time of registration to five.

Everyone told me to hire a Responsible Person agent. But the Responsible Person is accountable for safety substantiation and adverse event reporting, and I am the one who formulates the products. Handing that to a third party did not make sense. The FDA filings were manageable. Setting up the U.S. company was the slow part.

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.