Biowave Hit With Form 483 Over Quality Audits, Management Review

The FDA issued a Form 483 to Biowave, citing its quality audit procedures and management review.

The agency conducted an April inspection at the devicemaker’s Norwalk, Conn., facility and found the company’s procedures governing internal quality audits had not been established, a repeat observation.

Investigators further found that Biowave’s procedures for management review activities also had not been established. The company promised to correct both observations.