FDA WARNING_LETTER - Korea Pharma Company Ltd

The FDA issued a Warning Letter to Korea Pharma Company Ltd on March 26, 2012, for failing to fulfill drug establishment registration obligations. The company continued to manufacture and import drugs into the U.S. in 2011 and 2012 without registering its establishment, despite an August 8, 2011, notification from the FDA.

This failure violates Section 510(i)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 360(i)(1)), which requires annual electronic registration for foreign establishments manufacturing drugs imported into the U.S. It is also a prohibited act under Section 301(p) (21 U.S.C. § 331(p)). Additionally, drugs cannot be imported unless listed per 21 CFR Part 207, Subpart C, and manufactured at a registered foreign establishment (21 CFR § 207.40(b)).

Unregistered drugs may be refused admission under Section 801(o) (21 U.S.C. § 381(o)) and Section 801(a)(3) (21 U.S.C. § 381(a)(3)) if appearing adulterated or misbranded. Failure to list drugs as required by Section 51