Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).**
Passage 2You could not provide procedures, batch records, or other records to support the manufacturing operations performed at your facility.
Passage 3Additionally, the marketed drug products were not labeled with batch numbers and expiry dates.
Passage 4You could not provide sufficient documentation of the quality of incoming bulk materials, including identity testing or physical inspection of your incoming component containers.
Passage 5FDA laboratory testing of a batch of this product collected during the inspection found that the drug product contained on average 0% ethanol and an average of 58% methanol v/v.
Passage 6MEDICALLY MINDED 100% THC FREE Hand Sanitizer Gel is an unapproved new drug in violation of section 505(a) of the FD&C Act, 21 U.S.C.
Passage 7Global Sanitizers LLC has not fulfilled the registration requirement. As a result, all drugs manufactured in this establishment are misbranded under Section 502(o) of the FD&C Act [21 U.S.C.
Passage 8There are no drug listing submissions under the name of or labeler code for Global Sanitizers LLC.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 201.66(d)(7)
- 21 CFR 201.128
- 21 CFR 201.66(b)
- 21 CFR 207.17
- 21 CFR 210.3(b)(7)
- 21 CFR 210.3(b)(8)
- 21 CFR 210
- 21 CFR 211.22
- 21 CFR 314.3(b)
- 21 CFR 330.1(e)
- 21 CFR 330