Nelson Laboratories, LLC offers a variety of onsite sampling, testing and regulatory support services for United States Food and Drug Administration (US FDA) detentions. Our facilities in Salt Lake City, Utah, USA and Ontario, California, USA have assisted many customers with this complex regulatory process. A list of services is provided below.
US FDA may at times detain or hold product intended for market. For medical devices specifically, the agency may detain, quarantine, random sampling, and confirmatory testing to substantiate safety, label claims, or other factors. As stated on the US FDA web site:
“The Food, Drug, and Cosmetic Act authorizes FDA to detain a regulated product that appears to be out of compliance with the Act. The Inspection Refusal Report (IRR) reports on those products for which a determination was to refuse admission to part or all of the product offered for importation.
The IRR is generated from data collected by FDA’s Operational and Administrative System for Import Support (OASIS) and is updated monthly.”
To learn more about US FDA detentions visit the Import Refusal Report.
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Nelson Laboratories can provide manufacturers of medical device products with qualified third-party detention services for:
- On-site Sampling: Random and independent sampling of detained product at port or warehouse requiring full documentation, randomization and preparation for shipping to a qualified facility for subsequent testing or inspection.
- Testing Services: Depending on product type and compliance issue, the lab can support your third-party verification requirements. Examples of test services include:
- Medical and surgical glove leak and integrity tests
- Sterility assurance verification including product bioburden, objectionable organisms, sterility and organism identification
- Sterilization batch release documentation or review
- Packaging integrity
- Regulatory Support: Our services include the necessary documentation, attestation and processes with adherence to good laboratory practice (GLP) in order to ensure you have the documentation needed to successfully meet US FDA requirements.
- Fees: Additional fees may apply for FDA detention and regulatory services.
Contact us today for a quote or consult.