Faci S.P.A. – FDA Warning Letter, Jun 14, 2012

On May 24, 2012, the FDA issued a Warning Letter to Faci S.P.A. in Italy, citing violations of the Federal Food, Drug, and Cosmetic Act. The FDA's review of drug shipments to the U.S. and the company's registration records revealed that Faci S.P.A. failed to register its establishment for 2011 and 2012, despite continuing to manufacture and import drugs into the U.S.

This failure to register violates Section 510(i)(1) of the Act (21 U.S.C. § 360(i)(1)), which mandates annual electronic registration for foreign drug establishments. This is also a prohibited act under Section 301(p) of the Act (21 U.S.C. § 331(p)). Additionally, drugs manufactured at an unregistered foreign establishment or not properly listed are subject to refusal of admission under Section 801(o) and 801(a)(3) of the Act, and may be deemed misbranded under Section 502(o) (21 U.S.C. § 352(o)). The letter noted that any drug listings associated with the unregistered establishment would appear outdated, contributing to misbranding.

Faci S.P.A. was directed to immediately register its establishment and