Warning Letter: Similasan
Warning Letter: Similasan
On Aug. 16, The US Food and Drug Administration issued a Warning Letter to Similasan AG (Jonen, Switzerland).
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.
–Douglas McCormick
Full Tolerance Coverage Method for Assessing Uniformity of Dosage Units with Large Sample Sizes
March 10th 2025The ‘full tolerance coverage method’ is introduced as a coverage estimation approach for assessing the uniformity of dosage units from large sample sizes, ensuring that no dosage unit exceeds the specification range.
