FDA WARNING_LETTER - FC Company Limited - July 08, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to FC Company Limited of Sha Tin, Hong Kong SAR China, following an inspection from July 7-8, 2025. The inspection revealed that the firm"s medical device, Pocket BVM, was manufactured under conditions that did not conform with the current good manufacturing practice requirements of the Quality System regulation (21 CFR Part 820), rendering the products adulterated under the Federal Food, Drug, and Cosmetic Act.

Key violations included the failure to adequately establish and maintain procedures for receiving, reviewing, and evaluating customer complaints, as evidenced by undocumented email complaints. Additionally, the firm failed to properly control all required documents; specifically, the "FC-Test Report Checklist" forms, used for critical quality inspections, lacked revision levels, formal review, approval, and existed as uncontrolled, editable PDFs, allowing for unauthorized changes.

The FDA deemed the company"s initial responses to these observations inadequate, citing insufficient evidence of systemic corrections, training documentation, or plans to address past issues and ensure future compliance. FC Company Limited is required to respond in writing within thirty business days, detailing specific corrective actions, plans to prevent recurrence, and supporting documentation. A timetable for implementation is required if actions extend beyond this period.