DEPQ Internacional S. de R.L 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

Cleanhumans Hand Sanitizer and dgreen ADVANCED HAND SANITIZER ANTIBACTERIAL GEL, declared to be manufactured at your facility, are labeled to contain 60% of the active ingredient ethyl alcohol (ethanol). However, FDA laboratory testing of batches of these products detained at the border found that the drug products contained a range of between 1.5-1.7% volume/volume (v/v) ethanol in four samples. These hand sanitizer drug products are adulterated under section 501(c) of the FD&C Act in that the active ingredient of ethanol is present at levels in the products lower than that which is declared on their labeling.

Passage 2

dgreen ADVANCED HAND SANITIZER Alcohol Free, declared to be manufactured at your facility, is labeled to contain 10% of the active ingredient benzalkonium chloride (BZK). However, FDA laboratory testing of batches of this drug product detained at the border found that the drug product contained an average of 0.7% and 1.5% weight/volume (w/v) BZK in two samples. These hand sanitizer drug products are adulterated under section 501(c) of the FD&C Act in that the active ingredient of BZK is present at levels in the products lower than that which is declared on their labeling.

Passage 3

these products are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because Cleanhumans Hand Sanitizer, dgreen ADVANCED HAND SANITIZER ANTIBACTERIAL GEL and dgreen ADVANCED HAND SANITIZER Alcohol Free are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but do not comply with the requirements for marketing under that section and are not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C.

Passage 4

Cleanhumans Hand Sanitizer is misbranded under section 502(x) of the FD&C Act, 21 U.S.C. 352(x), because 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.

Passage 5

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

Passage 6

these hand sanitizers are misbranded under section 502(a) of the FD&C Act, 21 U.S.C 352(a), because their labeling is false and misleading. As noted above, Cleanhumans Hand Sanitizer and dgreen ADVANCED HAND SANITIZER ANTIBACTERIAL GEL are labeled to contain ethanol, 60%. However, FDA laboratory analyses of batches of these products demonstrate that the products contain concentrations of ethanol that is significantly far less than that stated on their respective product labels. Likewise, dgreen ADVANCED HAND SANITIZER Alcohol Free is labeled to contain benzalkonium chloride, 10%. However, FDA laboratory analysis batches of this product demonstrate that the product contains concentrations of benzalkonium chloride that is far less than that stated on its respective product label.

Passage 7

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