VeganicSKN Limited
3 extracted findings
FDA source excerpt, selected passage
Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).
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 thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).
Source passage selected by the model
02
Your firm failed to conduct at least one test to verify the identity of each component of a drug product. 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) and 211.84(d)(2)).
Source passage selected by the model
03
Your firm did not adequately test your incoming component, **(b)(4)**, for identity prior to use in manufacturing. **(b)(4)** is a component that is at high risk for **(b)(4)** contamination. Your firm also accepted the **(b)(4)** raw material based on the supplier’s certificate of analysis (COA), without establishing the reliability of each of your component suppliers’ analyses at appropriate intervals. Additionally, the **(b)(4)** lot you utilized for drug product production had expired.
Source passage selected by the model
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.