FDA WARNING_LETTER - C.I. Farmacapsulas S.A. - November 29, 2012

The FDA issued a Warning Letter to C.I. Farmacapsulas S.A. following a review of drug shipment entries and registration/listing information, which revealed significant non-compliance with the Federal Food, Drug, and Cosmetic Act. The primary violation identified was the firm's failure to register its foreign establishment annually for both 2011 and 2012, despite continuing to manufacture and import drugs into the United States. This constitutes a failure to fulfill registration obligations under section 510(i)(1) of the Act and is a prohibited act under section 301(p). Consequently, the lapsed registration renders any associated drug listings out of date, creating an appearance of misbranding under section 502(o) of the Act, as drugs must be listed per 21 CFR Part 207. To remedy these violations, C.I. Farmacapsulas S.A. must immediately register its establishment and ensure all drugs offered for import are properly listed. The firm is required to notify the FDA in writing within fifteen working days of receipt of the letter, detailing corrective actions. Failure to comply could result in drugs being refused admission into the U.S. under sections 801(o) and 801(a)(3) of the Act. The FDA also noted that registration and listing must now be submitted electronically via Structured Product Labeling (SPL).