Rohto Pharmaceutical Co., Ltd.
2 extracted findings
FDA source excerpt, selected passage
Your firm failed to adequately design, control, and supervise your aseptic processing line.
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 adequately design, control, and supervise your aseptic processing line.
Source passage selected by the model
02
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
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.