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
Benuvia Granted GMP Certification by Brazil National Health Surveillance Agency
March 14th 2025The certification allows Benuvia to produce pharmaceutical products for companies, either local to Brazil or international, that may be looking for compliant and high-quality production capabilities in the Brazilian pharmaceutical market.
