The U.S. Food and Drug Administration, also known as the FDA, has seized $346,954.43 worth of FastSize Extender devices and FastSize EQM Erectile Quality Monitor devices, in addition to component parts used in the manufacturing process of the Extender.  U.S. Marshall’s federal agents seized the unapproved devices, which were misbranded.  Also, there were a number of safety concerns not addressed.

According to the FDA, The FastSize Extender is considered misbranded and adulterated because they are unapproved and were manufactured under conditions that did not meet Good Manufacturing Practices (cGMP).  The warrant for FastSize was issued by the U.S. District Court for the Central District of California.  The FastSize Extender is manufactured and distributed by FastSize, LLC located in Aliso Viejo, Calif.

What is the FDAs main concern?

The device was promoted to help men gain length, girth, and overall penile health and to correct Peyronie’s disease also known as curved or bent penis.  Because the device is intended to cure, mitigate and treat a disease, it is subject to the regulatory authority of the FDA.  Unfortunately in this case, Fastsize does not have an approved application for this device, which is illegal.

What about inspections and compliance?

During a recent inspection of the their manufacturing facility, inspectors saw major deviations from cGMP regulations.  Also during the inspection, the inspectors realized that the extender device was not properly listed with the FDA as required by law, and worse yet, the company failed or refused to furnish information regarding the device to federal inspectors as required under the Medical Device Reporting regulation.

So, let this be a warning to you...never purchase any male enhancement product or penis extender without doing research.  Read the product reviews and company websites to verify they have proven medical studies and endorsements.  In the case of FastSize, it seems that the law has caught up with them lying about how they manufacture their products.  FastSize actually sourced their rip-off device from China.

The good news is that the federal government is finally cracking down on the companies who insist on selling sawdust and inferior products.  As mentioned, FastSize claimed to have medical grade and CE approval, but didn’t.  It is companies like them that give the whole industry a bad name.

The bottom line is there are top-notch, high quality products available.  For instance, SizeGenetics uses the most reputable supplier in the industry.  Perhaps that is why they continue to be the best brand in the market!

Stop using inferior products and go with a proven penis extender.  Read The Detailed SizeGenetics Review Now!

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