C-PAP devicemaker Somnowell landed a May 12 warning letter for numerous quality system violations, including failure to establish procedures for quality audits and management reviews.
The specification developer located in Bellevue, Tennessee was inspected Feb. 11 through March 10.
According to the letter, the firm failed to establish procedures for conducting quality audits, management reviews or procedures for evaluating suppliers. Indeed, the firm had not conducted any quality audits, supplier audits or management reviews.
Inspectors noted the firm did not establish a design history file to demonstrate that its C-PAP device was developed according to the approved design plan. Similarly, procedures were not established for design changes or for implementing corrective and preventive actions.
The firm also did not maintain a complaint file and had not established procedures for handling complaints, the agency said.