FDA WARNING_LETTER - Pan Drugs Limited

The FDA issued a Warning Letter to Pan Drugs Limited on February 28, 2012, due to the company's failure to fulfill drug establishment registration obligations. The FDA's review indicated that Pan Drugs Limited had not registered its establishment in 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 establishments manufacturing drugs imported into the U.S. This constitutes a prohibited act under Section 301(p) of the Act (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)). Failure to provide registration statements can lead to refusal of admission under Section 801(o) (21 U.S.C. § 381(o)). Furthermore, lapsed registration renders drug listings out of date, creating an appearance of misbranding under Section 502(o) (21 U.S.C. § 352(o)).

Pan Drugs Limited