Chara Biologics, Inc.: FDA Warning Letter (Jan 17, 2025)

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1
Your firm failed to establish a quality unit with the responsibility and authority to approve or reject all labeling and drug products, and the responsibilities and procedures applicable to the quality control unit are not in writing and followed, as required by 21 CFR 211.22(a) and 211.22(d).

Citations in the original letter

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

21 CFR 1271.10(a)
21 CFR 1271
21 CFR 1271.15
21 CFR 1271.55(d)(1)(iii)
21 CFR 1271.3(d)
21 CFR 1271.10(a)(1)
21 CFR 1271.3(f)(1)
21 CFR 1271.3(c)
21 CFR 1271.3
21 CFR 1271.20
21 CFR 1271.3(d)(3)
21 CFR 210.3(b)(12)
21 CFR 210
21 CFR 211.22(a)
21 CFR 211.160(b)
21 CFR 211.100(a)
21 CFR 211.192
21 CFR 211.198(a)
21 CFR 211.130