AriBio H&B 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 58% w/v ethanol.

Passage 2

you provided details on the test method for release of finished hand sanitizer products but did not provide any documentation of what methanol content test method you or your suppliers are using or a scientific rationale for your ethanol content test method. Without adequate testing of incoming raw materials, as is required under 21 CFR 211.84, you cannot assure that your drug products conform to appropriate standards of identity, strength, quality and purity.

Passage 3

The label includes the claims, “REDLAB Korea NO1 Dietary Supplement” and “H&B aribio Korea NO1 Dietary Supplement,” which imply that this product is a dietary supplement. However, the Uses and Directions sections of the Hand Sanitizer Original label indicate that the product is intended for use as a topical antiseptic, not for ingestion. Because the definition of dietary supplement specifies that a dietary supplement “is intended for ingestion” (section 201(ff)(2)(A)(i) of the FD&C Act, 21 U.S.C. 321(ff)(2)(A)(i)), Hand Sanitizer Original is not a dietary supplement. Declaring Hand Sanitizer Original to be a dietary supplement is therefore false or misleading.

Passage 4

the product label fails to disclose a domestic address or domestic telephone number through which the responsible person may receive a report of a serious adverse event with such drug.