US · 21 CFR

Findings citing 21 CFR 211.28

Personnel responsibilities.

6 findings citing this section, drawn from 5 published documents. The most recent cases are below; the full set is in search.

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Recent findings

US FDA Advanced Nutriceuticals, LLC dba The Guyer Institute of Molecular Medicine 2021-11-16

Your firm failed to ensure that manufacturing personnel wear clothing appropriate to protect drug product from contamination (21 CFR 211.28(a)).

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US FDA Infusion Options, Inc. 2021-11-09

Your firm failed to ensure that only personnel authorized by supervisory personnel enter those areas of the buildings and facilities designated as limited-access areas (21 CFR 211.28(c)).

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Section text

Read 21 CFR 211.28 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.