Since OEM Lasers was mentioned please notice that none of our portables is Class IV. The class IIIb systems all have key switches, beam delays, emission indicators, aperture covers, and interlocks. That's the way we roll. Because of this they are accessioned properly and always import without problems. Our largest purchaser of portables is the military followed by universities. We've probably sold two or so to hobbyists.
The OEM integration systems we offer, on the other hand, have no safety systems yet we have accessioned them as non-compliant systems and restrict their sale only to entities developing equipment requiring laser sources. Again, never any problems with import. Furthermore, we've never been flagged for any questionable imports and our volume of import clearly indicates a commercial concern.
I suspect the issue they are running into is fraudulent 2877s. They are probably using an accessioned class IIIb system to import the laser and someone caught it. I notice that the sample FDA 2877 has no manufacturer of record listed on the 2877. Hell, I'd flag that if I saw it.
The shipping company does not inspect the merchandise. They simply act as your agent when dealing with customs and FDA. As the agent, they make sure the commercial invoice, the bill of lading, and any declaration documents are submitted to customs and FDA. They don't make these up. These need to be supplied by the shipper or receiver. They then contact the necessary parties to get any missing documentation. The first contact is to the exporter. WL may not be responding to their requests and so the import just sits. They may then try to contact you for the documentation.
Not everything gets close inspection particularly if you are a regular importer. As long as you give the inspectors no reason to question the imports things run smooth. WL is identified to the FDA as a violator and they will get close inspection every single time the import is recognized. That's why you often see the originator company as something different then the company you purchased from. They are simply trying to dodge the flag set by the FDA.
It's unfortunate but it's the nature of the beast.
