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Barcode Better

At TEKLYNX, we believe barcode software isn’t just something you buy. It’s an integrated technology solution that makes your company work.

Learn More about FDA Labeling

TEKLYNX helps companies comply with FDA labeling standards in life sciences and food & beverage


The Food and Drug Administration (FDA) has several labeling standards and regulations that companies in various industries must adhere to. TEKLYNX offers a variety of barcode labeling solutions designed to help you comply with FDA labeling standards. 

 

How TEKLYNX helps:

 

  • Create FDA labels in varying sizes
  • One complete label design software for all FDA regulation labels
  • Database connections for real-time compliant data
  • Compatibility with 3000+ label printers
  • Label samples for free download to get started easily and quickly

 

 

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We’re here to help you find the best FDA labeling solution for your business

Life Sciences Labeling & Compliance

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FDA Life Sciences Labeling Regulations

 
  • FDA labeling regulations within the medical device industry include Unique Device Identification (UDI), which requires that all medical devices distributed in the United States be labeled with a UDI, comprised of a unique numeric or alphanumeric code that is used to identify medical devices within the supply chain.

  • FDA 21 CFR Part 11 applies to the research, manufacturing, and distribution of pharmaceutical and medical products, and was established to protect the public health and ensure accuracy of electronic medical records.

  • Drug Supply Chain Security Act (DSCSA) aims to build electronic interoperable systems to accurately trace prescription drugs throughout the supply chain. A unique product identifier is required at the prescription drug package level to meet DSCSA requirements. 

UDI Labeling

UDI requires that all medical devices distributed in the United States be labeled with a Unique Device Identifier (UDI), which is used to mark and identify medical devices within the supply chain

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FDA 21 CFR Part 11 Compliance

FDA 21 CFR Part 11 protects public health and ensures accuracy of electronic medical records

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DSCSA Labeling

Easily create serial numbers to be labeled on prescription drugs to comply with the FDA's Drug Supply Chain Security Act (DSCSA)

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Validate your company's labeling processes quickly

Save time and resources by accelerating your validation of labeling processes

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Ready to get started with validation?

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Navigating Food Labeling Requirements

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FDA Food Labeling Regulations

 

  • The updated Nutrition Facts label for packaged foods is required to be used by manufacturers within the US or those exporting goods into the US. Read our blog, How to Make Nutrition Labels for North America to see all the new requirements needed for FDA nutrition labeling.

  • The Food Safety Modernization Act (FSMA) Final Rule for Preventive Controls for Human Food requires food manufacturers to establish and implement a food safety system that includes an analysis of hazards and risk-based preventive controls.

  • Incorrect packages or labels that fail to identify allergens are the leading cause of food recalls by the FDA and the US Department of Agriculture (USDA). The US requires 8 common allergens to be highlighted on food labels, and the European Union requires 14 to be highlighted.

Nutrition Facts Labeling

Be prepared to comply with the Nutrition Facts label by leveraging label templates with variable data

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FSMA Compliance

Secure label approval, traceability, and label storage software helps you comply with food & beverage industry standards and regulations such as the Food Safety Modernization Act (FSMA)

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Food Allergen Labeling

Automate stylistic differences for allergens when they appear in an ingredients list to comply with EU Regulation 1169/2011 on the Provision of Food Information to Consumers (FIC)

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Get in touch

Want to learn more about how TEKLYNX can help you comply with FDA labeling standards and regulations? Fill out the short form and we'll be in touch.

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