Simex Logistics 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

FDA laboratory testing of a batch of this product detained at the border found that this product contained an average of 51% ethanol volume/volume (v/v).

Passage 2

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

Passage 3

Your gel formulation does not appear to have uniform character and quality.

Passage 4

you acknowledged that Simex released at least two of the (b)(4) lots to the U.S. market without performing finished product testing, a violation of 21 CFR 211.165.

Passage 5

The method of in-house testing uses a refractometer device that is unsuitable for the testing of finished hand sanitizers that contain materials other than ethanol and water in their matrix.

Passage 6

Furthermore, you state that due to the “antiseptic nature of the product” there is no testing performed for objectionable microbiological contamination.

Passage 7

HEALTH & HAND GEL HAND SANITIZER is labeled to contain ethyl alcohol 70%. However, FDA laboratory analyses of a batch of this product demonstrate that the product contains a concentration of ethyl alcohol (ethanol) that is less than what is stated on the product label.

Passage 8

this product is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee) because HEALTH & HAND GEL 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.

Passage 9

No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for this drug product, nor are we aware of any adequate and well-controlled clinical studies in the published literature that support a determination that your HEALTH & HAND GEL HAND SANITIZER drug product is GRASE for use under the conditions suggested, recommended, or prescribed in its labeling. Accordingly, this product is an unapproved new drug marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).