Guangzhou Jiugong Research And Development Biotechnology Co., Ltd.
3 extracted findings
FDA source excerpt, selected passage
Based on our review of drug product labels, the “(b)(4)” contains the color additive “CI 16185” (also known as FD&C Red No. 2 or Amaranth). In 1976, FDA cancelled the certification and delisted FD&C Red No. 2 because it could not be proven safe for use.
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
Based on our review of drug product labels, the “(b)(4)” contains the color additive “CI 16185” (also known as FD&C Red No. 2 or Amaranth). In 1976, FDA cancelled the certification and delisted FD&C Red No. 2 because it could not be proven safe for use.
Source passage selected by the model
02
Your firm’s quality unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).
Source passage selected by the model
03
The records and information provided demonstrate that the quality unit (QU) did not effectively exercise its responsibilities to oversee the quality of the drug manufacturing operations. The response includes discrepancies between the color additive on the labeling versus the batch formulation spreadsheet versus the color specified in the certificate of analysis (COA).
Source passage selected by the model
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.