FDA: HMI Failed to Conduct Proper Quality System Audit

April 5, 2010
HMI Industries has been warned for good manufacturing practice violations related to its air-filtration devices, including failure to conduct quality audits. The Strongsville, Ohio, company’s audit procedure did not address the frequency of audits or assure the entire quality system would be covered, according to a Feb. 23 warning letter posted recently to the FDA’s website. The company had not conducted a management review since 2004, the letter notes.
The GMP Letter