This site is intended for Healthcare professionals only.

Repro Med Systems issued a warning by the FDA

Repro Med Systems issued a warning by the  FDA

New York: Repro Med Systems, Inc. dba RMS Medical Products (OTCQX: REPR), a leading developer and manufacturer of medical devices and supplies, announced that on February 26, 2016, RMS Medical Products, Inc. (“RMS”) received a Warning Letter (WL NYK-2016-26) from the New York District Office of US Food and Drug Administration (“FDA”) based on the observations of an FDA inspection which occurred in June 2015.

During the audit, the FDA identified several areas of improvement; many of those items have been completed to the agency’s satisfaction. There are three items that require additional clarification and RMS Medical Products is in the process of addressing these issues and providing the additional documentation needed.

There were no safety concerns raised by the points made in the warning letter.

“While we anticipate one item taking a bit longer to resolve, the others are merely an exercise in better communicating our thorough processes and premium safety standards to the FDA,” said Dr. Fred Ma, Chief Medical Officer at RMS Medical Products. “As always, we remain committed to uncompromised safety and quality for all of our products.”

Dr. Ma and RMS Medical Products’ management are working in collaboration with external FDA consultants and investigators to remediate all matters as efficaciously as possible. While the three items are being addressed, the company will continue to operate in full compliance with all ISO 13485 and FDA QSR regulatory requirements (i.e. 21CFR Part 820) applicable to their products.

The company is directing all inquiries to Corinne Colaianni at 845.469.2042.



Source: self
0 comment(s) on Repro Med Systems issued a warning by the FDA

Share your Opinion Disclaimer

Sort by: Newest | Oldest | Most Voted