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FDA Warning Letter Explorer
FDA warning letter · Drugs

Les Importations Herbasanté 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 appropriately sample, test, or examine the components, containers or closures released for use in the manufacture of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84).

Passage 2

Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).

Citations in the original letter

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

  • 21 CFR 210
  • 21 CFR 211.84
  • 21 CFR 211.100(a)
  • 21 CFR 211.22
  • 21 CFR 211.180(e)
  • 21 CFR 211.22(a)
  • 21 CFR 211.186
  • 21 CFR 211.188(b)