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FDA Warning Letter Explorer
FDA warning letter · Drugs

Safecor Health, LLC

Issued · Posted by FDA

FDA published a close-out letter on Feb 10, 2025. 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

Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)).

Passage 2

Your firm failed to test samples of each component for conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(2)).

Passage 3

Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.

Citations in the original letter

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

  • 21 CFR 210
  • 21 CFR 211.130(e)
  • 21 CFR 211.67(b)
  • 21 CFR 211.84(d)(2)
  • 21 CFR 211.22