Oneida Times

Memory MD, Inc. in New York, New York was inspected by the Food and Drug Administration (FDA) on July 3 for post-market assurance for devices and received three citations, according to data posted on the FDA’s official website.

The FDA website indicates that the citations were delivered to the company as follows:

'The design review results, including the date and the individual(s) performing the review, were not documented in the design history file.'

'The results of design validation, including method(s), were not adequately documented in the design history file.'

'A device history record has not been adequately maintained.'

The FDA routinely inspects facilities across the nation to determine if the workplaces and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly for businesses to consistently make smarter business decisions for the future.

The FDA is a government agency that is primarily responsible for monitoring the manufacturing and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.