Hou Fu Biotech - Jiangsu Co., Ltd

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

FDA laboratory testing of a batch of this product detained at the border found that the drug product contained an average of only 45% v/v ethanol. This hand sanitizer drug product is adulterated under section 501(c) of the FD&C Act in that the active ingredient of ethanol is present at levels in the product lower than that which is declared on its label.

Passage 2

The subpotency of hand sanitizer drug products declared to be manufactured in your facility demonstrates that the quality assurance within your facility is not functioning in accordance with CGMP requirements under section 501(a)(2)(B) of the FD&C Act.

Passage 3

PANROSA Instant Hand Sanitizer is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a)

Passage 4

PANROSA Instant Hand Sanitizer is also misbranded under section 502(f)(2) of the FD&C Act 21 U.S.C.352(f)(2), because the product label does not include all of the applicable warnings as required under 21 CFR 330.1(g). Specifically, the label does not include the warning statement that reads, “If swallowed, get medical help or contact a Poison Control Center right away.”

Passage 5

this product is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee) because PANROSA Instant Hand Sanitizer is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but does not comply with the requirements for marketing under that section and is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.