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FDA Warning Letter Explorer
FDA warning letter · Drugs

Grupo Plast-Y-Kosas, SA de CV

Issued · Posted by FDA

Selected passages from the FDA letter

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

Passage 1

In addition, this product is adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)), in that the substitution demonstrates that the quality assurance within your facility is not functioning in accordance with Current Good Manufacturing Practice (CGMP) requirements.

Passage 2

Additionally, M HAND SANITIZER is misbranded under sections 502(j) and (e) of the FD&C Act, 21 U.S.C.

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 201.128
  • 21 CFR 330.1(e)
  • 21 CFR 330