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FDA Warning Letter Explorer
FDA warning letter · Drugs

QuVa Pharma, Inc.

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

Your firm failed to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).

Citations in the original letter

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

  • 21 CFR 200.10(b)
  • 21 CFR 210
  • 21 CFR 210.1(b)
  • 21 CFR 211.113(b)
  • 21 CFR 211.42(c)(10)(iv)
  • 21 CFR 211.192
  • 21 CFR 211.100(a)
  • 21 CFR 211.68(b)