US · 21 CFR

Findings citing 21 CFR 211.94

Drug product containers and closures.

3 findings citing this section, drawn from 3 published documents. The most recent cases are below; the full set is in search.

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Recent findings

US FDA Right Value Drug Stores, LLC dba Carie Boyd Pharmaceuticals 2025-03-11

Your firm failed to clean and sterilize and process, where indicated by the nature of the drug, container closures to remove pyrogenic properties to assure they are suitable for their intended use (21 CFR 211.94(c)).

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US FDA Sagent Pharmaceuticals, Inc. 2022-12-20

Your firm failed to ensure container closure systems provide protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product (21 CFR 211.94(b)).

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

Your firm failed to clean and sterilize and process, where indicated by the nature of the drug, container closures to remove pyrogenic properties to assure they are suitable for their intended use (21 CFR 211.94(c)).

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Terms related to this section

Container Closure System

Section text

Read 21 CFR 211.94 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.