FHC, Inc. in Bowdoin, Maine was inspected by the Food and Drug Administration (FDA) on July 24 for device compliance 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 identification of the design, the date and the individual(s) performing the review, were not documented in the design history file.’
‘The device design was not correctly translated into production specifications.’
‘Procedures for corrective and preventive action have not been adequately established.’
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.
