My source is having been a shareholder of this company for 7 years and having read the announcements during that time.
Both China and USA require product specific approvals.
Mataura and Synlait meet FDA and SAMR standards for facilities that produce infant formula and have certificates registering this. It is not the same thing as having a product approval though.
US FDA Eases Baby-Formula Import Rules to Boost US Supplies, page-19
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