Inovaker Lab S.A. de C.V.

Selected passages from the FDA letter

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

Passage 1

However, FDA laboratory testing of a batch of this product detained at the border found that the drug product contained no ethanol or 0% v/v.

Passage 2

the subpotency demonstrates that the quality assurance within your facility is not functioning in accordance with Current Good Manufacturing Practice (CGMP) requirements.

Passage 3

this product is an unapproved new drug marketed in violation of sections 505(a) and 301(d) of the FD&C Act

Passage 4

“Hand Sanitizer . . . Drug Facts . . . Purpose Antiseptic . . . Use(s) Health care personnel hand rub to help reduce bacteria that potentially can cause

Passage 5

Such a product does not conform to the TFM or the other applicable requirements, nor is it consistent with the formulations described in the guidances