Richway International is committed to providing safe and reliable products to its customers.  I have received several inquiries from people inquiring about the Biomat® FDA Warning Letter that was mentioned on some competitors websites.  This was issued to Richway NF in January, 2013, regarding the manufacturing processes of the Biomat®.  This is something that occurred several years ago and was resolved.  How do you know this was resolved?  The Biomat is still available for sale.  Richway would not be able to continue selling the Biomat if it procedural issue wasn’t fixed.

This FDA letter reviews several items where Richway NF (the company that was manufacturing the Biomat) was failing to meet procedures which are required in the manufacturing of medical devices that are regulated under the FDA.  The letter was also cc’d to Richway International in Hawaii, USA.

Meeting Richway International’s clients’ quality needs and expectations is very important to Richway International. To resolve this issue, Richway International began working with another organization, that is qualified and trained in the procedures to be fully compliant with the FDA requirements.  R&L Co. is now manufacturing the Biomat® for Richway International and this change has addressed any concerns raised in the manufacturing process raised by the FDA.

If Richway did not make changes to meet the FDA manufacturing process requirements, then the Biomat® would have been taken off of the market.  Richway would not be able to sell it.  It has been several years since this warning was issued, and if it had not been resolved in a manner that meets the FDA requirements, then you would not see it for sale.

I would be happy to answer any further questions about this.  You can reach me through the contact link above.  Alternatively, you can speak with a representative from Richway directly by contacting their North American head office in Hawaii:

customerservice@richwayusa.com or calling toll free (in North America) 1-855- 338-6410