Jiangmen Shuizirun Sanitary Articles Co., Ltd.
4 extracted findings
FDA source excerpt, selected passage
Failure to establish procedures designed to prevent micro-contamination in products purporting to be sterile (21 CFR 211.113(b).
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 procedures designed to prevent micro-contamination in products purporting to be sterile (21 CFR 211.113(b).
Source passage selected by the model
02
Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1), 211.84(d)(2) and 211.110(c)).
Source passage selected by the model
03
You failed to adequately test each shipment of each lot of **(b)(4)**, used as an active pharmaceutical ingredient, for **(b)(4)**. The use of **(b)(4)** contaminated with **(b)(4)** has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document **(b)(4)**.
Source passage selected by the model
04
You failed to adequately test each shipment of each lot of **(b)(4)**, used as an inactive ingredient, for **(b)(4)** contamination.
Source passage selected by the model
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.