FDA WARNING_LETTER - Hou Fu Biotech - Jiangsu Co., Ltd - April 20, 2021

The FDA issued a Warning Letter to Hou Fu Biotech (Jiangsu) Co., Ltd. after testing a consumer antiseptic hand rub, PANROSA Instant Hand Sanitizer, declared to be manufactured at their facility. The product was detained and refused admission into the U.S. due to adulteration and misbranding.

FDA testing revealed the hand sanitizer, labeled to contain 70% v/v ethyl alcohol, only contained an average of 45% v/v, falling below the recommended 60% minimum. This constitutes adulteration under section 501(c) of the FD&C Act and indicates a failure of quality assurance under CGMP requirements (section 501(a)(2)(B)).

Furthermore, PANROSA Instant Hand Sanitizer is an unapproved new drug, violating section 505(a) of the FD&C Act, as it is not generally recognized as safe and effective (GRASE) and lacks FDA approval. It also does not conform to the 1994 Tentative Final Monograph or temporary COVID-19 policies for hand sanitizers.

The product is misbranded under section 502(a) for false labeling regarding active ingredient concentration, section 502(f)(2) for lacking required warnings (e.g., "If swallowed..."), and section 502(ee) for non-compliance with Section 505G requirements for