FDA warning letter · Drugs

Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil

Issued · Posted by FDA

FDA published a close-out letter on Jun 9, 2026. The passages below are from the original warning letter.

Selected passages from the FDA letter

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

Passage 1

However, the methods you submitted did not include an appropriate identity test for ethanol, nor did the methods include testing for methanol, as required under 21 CFR 211.84. In addition, your test methods did not include appropriate assay testing for finished product as required per 21 CFR 211.165.

Citations in the original letter

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

  • 21 CFR 211.84
  • 21 CFR 211.165