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21 CFR 211.28 Personnel Responsibilities

(a) 

Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.

(b) 

Personnel shall practice good sanitation and health habits.

(c) 

Only personnel authorized by supervisory personnel shall enter those areas of the buildings and facilities designated as limited-access areas.

(d) 

Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions that may adversely affect the safety or quality of drug products shall be excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of drug products. All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products.

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Signify helps regulatory and product compliance teams in CPG and durables manufacturing launch products faster by automating global compliance.

Signify is the leading compliance system for consumer products—leveraging AI agents to automate gap analysis, streamline conformity checks, and accelerate safe, high-quality product launches.

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21 CFR

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Labeling

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Import & Export

Signify SOC2 Type 2 Compliant

© 2025 Signify Technologies, Corp.

Compliance AI Agents

for consumer products

Signify helps regulatory and product compliance teams in CPG and durables manufacturing launch products faster by automating global compliance.

Signify is the leading compliance system for consumer products—leveraging AI agents to automate gap analysis, streamline conformity checks, and accelerate safe, high-quality product launches.

Signify SOC2 Type 2 Compliant

© 2025 Signify Technologies, Corp.

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Signify helps regulatory and product compliance teams in CPG and durables manufacturing launch products faster by automating global compliance.

Signify is the leading compliance system for consumer products—leveraging AI agents to automate gap analysis, streamline conformity checks, and accelerate safe, high-quality product launches.

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Labeling

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Import & Export

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Why Now

21 CFR

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Signify SOC2 Type 2 Compliant

© 2025 Signify Technologies, Corp.