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FDA Warning Letter Explorer
Drugs · Jan 22, 2025

Nubratori, Inc. dba Nubratori Rx

6 extracted findings

FDA source excerpt, selected passage

Your firm failed to establish acceptance criteria for the sampling and testing conducted by the quality control unit that are adequate to assure that batches of drug products meet each appropriate specification and appropriate statistical quality control criteria as a condition for their approval and release. (21 CFR 211.165(d))

FDA published a close-out letter on Jul 30, 2026. 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
Your firm failed to establish acceptance criteria for the sampling and testing conducted by the quality control unit that are adequate to assure that batches of drug products meet each appropriate specification and appropriate statistical quality control criteria as a condition for their approval and release. (21 CFR 211.165(d))
02
Your firm failed to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile. (21 CFR 211.113(b))
03
Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas. (21 CFR 211.42(c)(10)(iv))
04
Your firm failed to follow written procedures for cleaning and maintenance of equipment. (21 CFR 211.67(b))
05
Your firm failed to conduct microbiological testing before use of each lot of a component with potential for objectionable microbiological contamination in light of its intended use. (21 CFR 211.84(d)(6))
06
Your firm failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals. (21 CFR 211.84(d)(2))

Sections and clauses cited

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

21 CFR 21021 CFR 211.165(d)21 CFR 211.113(b)21 CFR 211.42(c)(10)(iv)21 CFR 211.67(b)21 CFR 211.84(d)(6)21 CFR 211.84(d)(2)21 CFR 210.1(b)21 CFR 200.10(b)

For background, see Current good manufacturing practice (CGMP). Explore Botable’s work in Pharmaceuticals and Quality and regulatory operations.

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