Thursday 14 May 2015

What are the Import Requirements for FDA Regulated Products into the US at the Port of Entry



Importers of FDA regulated products to US must comply with the import requirements of the FDA and the Customs. All imported products must meet the exact standards as domestic goods. FDA is required to assure products are not adulterated or misbranded based on evidence. Here are a few examples of the productsthat are imported into the US: Drugs (human and animal), Medical devices, Biologics (including human cells and tissues), Cosmetics, Dietary supplements, Food and Tobacco.

The very first step before importing a product is reviewing the documents that proves the origin, content, certificates, storage, shipping conditions, destination, FDA approval documents, etc. The other step that needs to be followed are a) physical appearance: checking for the presence of filth, packaging defects, decomposition, mishandling or misbranding. B) Sampling: Collected, packed and shipped to FDA labs for testing and analysis. C) Analysis and conclusions: No violation or Specific violation.

A product could be detained if it appears to be non-compliant based on the above mentioned criteria such as improper documentation, dissatisfactory physical appearance, etc. Once the product gets detained, a detention notice will be sent to the importer and consignee sighting the reasons for detention. The manufacturer will be provided with the right to respond timeframe for response and contact information of FDA reviewer. Once the detention Hearing Process is been scheduled, importer can take possession and return. Importer can provide evidence to refute appearance or petition to recondition with FDA approval. The detention can be “overturned” or “stand (Refusal).”

Get a broader knowledge on importrequirements from Mukesh Kumar, Senior Director Regulatory Affairs and Quality Assurance at Onlinecompliancepanel.com.

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