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FDA Warning Letter Explorer
FDA warning letter · Drugs

Darmerica, LLC

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

Failure of your quality unit to exercise its responsibility to ensure that APIs manufactured at your facility are in compliance with CGMP.

Citations in the original letter

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

  • 21 CFR 201
  • 21 CFR 207
  • 21 CFR 207.49(a)(4)
  • 21 CFR 207.41(a)