FDA WARNING_LETTER - Aino Co., Ltd. of North China Pharmaceutical Group - December 14, 2012

The FDA issued a Warning Letter to Aino Co., Ltd. of North China Pharmaceutical Group on August 30, 2012, due to failure to fulfill drug establishment registration obligations. The company continued to manufacture and import drugs into the U.S. in 2011 and 2012 without annual registration, a violation of Section 510(i)(1) and 301(p) of the Federal Food, Drug, and Cosmetic Act (the Act).

The FDA had previously notified Aino Co., Ltd. on October 11, 2011, about their unregistered status. Unregistered establishments and unlisted drugs are subject to refusal of admission under Section 801(o) and 801(a)(3) of the Act, and drugs may be deemed misbranded under Section 502(o) if not properly listed per 21 CFR Part 207.

Aino Co., Ltd. was required to immediately register their establishment and properly list all drugs offered for import. They were given fifteen working days to notify the FDA in writing of corrective actions taken, or provide a reason for delay and a new completion date. Failure to comply could result in refusal of drug imports and notification to importers/consignees. The FDA emphasized that registration and listing must now be submitted electronically via Structured Product Labeling (SPL).