Three Common Errors for FDA Audits

Regulatory import compliance can be stressful, especially when dealing with a partner government agency such as the Food & Drug Administration (FDA).  Reviews and audits can be complex and difficult to prepare for as new regulations and programs are implemented.

The following are three of the most common issues identified during FDA audits:

Product Descriptions

• Be sure to stay consistent and use laymen’s terms
  • FDA recommends placing the descriptor before the product name and model
• Double check parts database during initial entry
  • Reduces the likelihood of repetitive errors

Dual Use Imports

• Multi-use and dual-use imports must have an end-use documentation in the entry file
  • e. Blue-1
    • Color can be in food, drinks, and cosmetics therefore, U.S. Customs and the FDA must be aware of its final use, as well as its destination.
  • e. Chemicals in odd quantities
    • Sodium fluoride and sodium bifluoride are both insecticides while ammonium bifluoride and potassium bifluoride are wood preservatives.
    • All of these chemicals are precursors to Sarin, a chemical nerve agent that causes the body to go into hyper drive, deteriorating the body by removing its ability to control itself.

Beware the Details

• Lasers
  • Lasers must have its accession number and 2877 form uploaded into ITACS.
• Compression Garments
  • Clothing of this nature is considered a device due to therapeutic application
    • Medical devices are FDA regulated
  • First-Aid Kits
    • Contents of kits may have separate device listings therefore each item must be a separate line item.
    • Each device is FDA regulated 

Following these simple guidelines may be the difference between a small error percentage and increased targeting for reviews and examinations.  For more information regarding regulatory compliance, visit www.fda.gov.

AUTHOR: Cityana Demase, Compliance Specialist Intern