US · 21 CFR

Findings citing 21 CFR 211.125

Labeling issuance.

4 findings citing this section, drawn from 4 published documents. The most recent cases are below; the full set is in search.

Search all 21 CFR 211.125 findings

Recent findings

US FDA Uriel Pharmacy, Inc. 2025-11-18

Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)). Your quality unit (QU) did not effectively exercise its responsibilities to oversee the quality of your drug manufacturing operations. Specifically, your QU failed to ensure adequate written procedures were in place…

See every finding in this document View official source
US FDA LS Promotions Inc. 2024-08-13

Your firm’s quality control 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). Your quality unit (QU) did not provide adequate oversight for the manufacture of your drug products. For example, your QU failed to ensure the following: • Establishment of adequate procedures describing the QU’s responsibilities (21 CFR…

See every finding in this document View official source

Terms related to this section

Mix-upReconciliation

Section text

Read 21 CFR 211.125 on eCFR

Other sections

21 CFR 210.121 CFR 211.10021 CFR 211.10121 CFR 211.11021 CFR 211.11321 CFR 211.12521 CFR 211.13021 CFR 211.13721 CFR 211.14221 CFR 211.16021 CFR 211.16521 CFR 211.16621 CFR 211.16721 CFR 211.17021 CFR 211.18021 CFR 211.18221 CFR 211.18621 CFR 211.18821 CFR 211.19221 CFR 211.19421 CFR 211.19821 CFR 211.2221 CFR 211.2521 CFR 211.2821 CFR 211.3421 CFR 211.4221 CFR 211.5621 CFR 211.5821 CFR 211.6321 CFR 211.6721 CFR 211.6821 CFR 211.8021 CFR 211.8421 CFR 211.94

These findings are a record of the moment each document was published. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out — do not read them as the current state; check the regulator's official announcements for the latest status. Findings are extracted automatically from the regulator's published documents, and section citations are counted exactly as written in the source. “View official source” on each case links directly to that document.