FDA WARNING_LETTER - Orlane S.A. - April 19, 2012

This FDA Warning Letter, WL: 300-12-005, dated March 15, 2012, was issued to Orlane S.A. in Orleans, France, regarding non-compliance with drug establishment registration and listing requirements. The FDA's review of import entries and registration records revealed that Orlane S.A. failed to register its establishment for 2011 or 2012, despite continuing to manufacture and import drugs into the United States.

This failure violates Section 510(i)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 360(i)(1)), which mandates annual electronic registration for foreign drug establishments. It is also a prohibited act under Section 301(p) of the Act (21 U.S.C. § 331(p)). Furthermore, drugs cannot be imported unless manufactured at a registered establishment and listed per 21 CFR Part 207, Subpart C. Failure to list drugs as required by Section 510(j) or provide necessary information renders drugs misbranded under Section 502(o) (21 U.S.C. § 352(o)). Unregistered establishments and outdated drug listings (due to lapsed registration) can lead to refusal of admission under Sections 801(o)