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FDA Warning Letter Explorer
FDA warning letter · Biologics

Toxikon Corporation/Labcorp Bedford LLC

Issued · Posted by FDA

FDA published a close-out letter on Nov 2, 2022. 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

Failure to adequately address this matter may lead to regulatory action. Failure to respond to this letter and to take appropriate corrective action could result in FDA taking regulatory action without further notice to you. If you believe that you have complied with the FD&C Act and FDA regulations, please include your reasoning and any supporting information for our consideration.

Citations in the original letter

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

  • 21 CFR 58.33(b)
  • 21 CFR 58
  • 21 CFR 58.35(b)(6)