OR WAIT null SECS
Warning Letter: Similasan
The agency’s concerns centered on filling processes and handling of sterilization filters. The letter cited “inadequate” heat-penetration studies of the filter autoclaving process and challenged the company’s practice of re-using filters up to 50 times without bacterial retention tests.
The agency was also concerned about the controls to prevent microbial contamination of sterile eye drops, the lack of written procedures to validate filling processes, and incomplete production and control information in the batch records.