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FDA Warning Letter Explorer
FDA warning letter · Biologics

Surgenex LLC

Issued · Posted by FDA

FDA published a close-out letter on Sep 29, 2023. 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 establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including procedures for validation of all aseptic and sterilization processes [21 CFR 211.113(b)].** For example:

Passage 2

Failure to establish written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess [21 CFR 211.100(a)].** Specifically, you have not validated the manufacturing processes for SurCord® and SurFactor® with respect to identity, strength, quality, and purity.***1

Passage 3

Failure to establish and follow a written testing program designed to assess the stability characteristics of drug products and to use the results of such stability testing to determine appropriate storage conditions and expiration dates [21 CFR 211.166(a)].** Specifically, your firm has assigned **(b)(4)** expiration date to your products without supporting data.

Citations in the original letter

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

  • 21 CFR 1271.10(a)
  • 21 CFR 1271
  • 21 CFR 1271.15
  • 21 CFR 1271.3(d)
  • 21 CFR 1271.10(a)(2)
  • 21 CFR 1271.3(c)
  • 21 CFR 1271.10(a)(1)
  • 21 CFR 1271.3(f)(1)
  • 21 CFR 210
  • 21 CFR 211.113(b)
  • 21 CFR 211.42(c)(10)(iv)
  • 21 CFR 211.100(a)
  • 21 CFR 211.192
  • 21 CFR 211.166(a)
  • 21 CFR 312