Many Firms Affected By Electronic Product FDA Labeling Violations

In 2010 the Food & Drug Administration (FDA) has added nine new products to Import Alert #95-04, which includes the detainment without the requirement of physical examination of the following products: laser gun sights, light shows, levels, pointer key chains, pointers and any other similar type laser products that do not comply with the FDA’s performance standards and reporting requirements as described in the June 3, 2010 Import Alert.

The FDA has regulatory jurisdiction over any and all electronic products capable of emitting radiation: both domestic and of foreign build. As reported by Benjamin L. England, of FDA, LLC, “Enforcement on laser pointers was big in the mid 90’s when I worked at the FDA; it appears as though this isn’t something they are going to ‘lighten up on'”. Any shipment may be subject to detention upon first attempt of entry without proper certification that a Laser product has met the Performance Standards (21 CFR 1010.2, 1010.3, 1040.10 and 1040.11) and will be subject to all future entries as well.

More than 60 firms have been placed on the Import Alert #95-04 Red List for importing a range of laser products that do not comply with FDA labeling and safety data. Violations have included failure to provide the required certifications and warnings, submitting false entry documents, or not submitting the correct safety documentation to the FDA’s Center for Devices and Radiological Health (CDRH). Any firm placed on IA #95-04 will have their products Detained Without Physical Examination (DWPE) at Customs. “Recent enforcement activities indicate that a firm may be placed on [Import Alert] #95-04 for only one violation,” Mr. England states “…once a shipment is found to be in violation, the manufacturer has to act quickly. If they don’t promptly show that the product is certified or up to FDA standards, the shipment will most likely be rejected and they may end up on the automatic detention [Import Alert].”

Mr. England says that it is also important to note that not every charge made by the FDA is correct in relation to imported electronic products. In many cases, the FDA has refused or detained laser pointer, DVD reader and CD player shipments simply because the importer did not provide the FDA “accession number” at the time of import. This however, is not a violation of the law. FDA accession numbers are not required by federal statutes and regulations in order to avoid being placed on detention. The law requires that manufacturers certify that their products are in compliance with regulatory performance standards and that they submit product reports to verify this. However, the FDA has recently started using the lack of an “accession number” as a way to put the importer on violation. Unfortunately, many importers are not aware of this fact and have ended up exporting large product shipments that could have been allowed into the US if only they’d had professional consultants like, LLC working on their behalf. The FDA identified eight different companies in the San Francisco port of entry alone, according to the #95-04 Import Alert. Due to violations discovered in the FDA’s surveillance program, all eight were placed on the Red List. Mr. England warns importers to expect the FDA to expand surveillance on this matter.

If your company has been placed on the Red List for IA #95-04, currently have shipments of electronic products that are subject to DWPE according to the FDA, or are uncertain if you have the required certification and documentation for import, let, LLC show you ‘the way through’., LLC is a consulting firm that assists importers in compliance with federal laws and regulations as well as expert know-how on helping you correct any current violations that may have caused you to end up on the Import Alert #95-04 Red List. can help you stay off Import Alerts. If your company has complications similar to those mentioned above, or wishes to avoid such expensive business problems, contact, LLC for solutions and advice.

Uk marriage visa was founded by Benjamin L. England, Esq., a former FDA professional with 20 years of direct FDA experience, 17 years of which were obtained inside FDA. Mr. England is now a privately practicing FDA lawyer managing food, drug, medical device, cosmetic, and electronic product regulatory compliance, international trade and customs law. specializes in making the complex understandable.

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