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FDA Warning Letter Explorer
Biologics · Nov 15, 2021

Surgenex LLC

3 extracted findings

FDA source excerpt, selected passage

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:

FDA published a close-out letter on Sep 29, 2023. The findings below are from the original warning letter.

Findings and supporting evidence

Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.

Findings extracted from the letter

Selected FDA passages, not the complete letter.

01
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:
02
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
03
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.

Sections and clauses cited

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

21 CFR 1271.10(a)21 CFR 127121 CFR 1271.1521 CFR 31221 CFR 21021 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 211.113(b)21 CFR 211.42(c)(10)(iv)21 CFR 211.100(a)21 CFR 211.19221 CFR 211.166(a)

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