A warning letter posted last month cites unapproved changes to ASP’s Sterrad CycleSure Biological Indicator, including a revision of the instructions for use and a change in a component. A new 510(k) should have been submitted, the agency says.
The letter, which stems from a four-month inspection of ASP’s Irvine, Calif., facility last year, also cites the company for corrective action failures. For example, ASP took inadequate actions to correct and prevent recurrence of sterilizers emitting oil mist, the FDA says.
The GMP Letter