Issues in Clean Room at Contract Manufacturer of sterile Eye Preparations resulted a warning letter

Optikem International Inc. received a Warning Letter from the FDA for significant issues in aseptic manufacturing and facility conditions. The FDA found the production environment unsuitable due to an unprotected production line and inadequate structural design. The cleanroom had unsuitable materials, including rust and damaged equipment.

Environmental monitoring was deemed insufficient, with inadequate frequency and parameters, and recurring fungal and bacterial contamination. Media fills were infrequent and did not cover the actual filling time, with the last fill conducted in October 2021 despite recent sterile product distribution.

The FDA also noted inadequate employee training on protective clothing, poor sterilization practices, and a lack of process validation. The manufacturer failed to validate manufacturing processes and water systems used in production. For more details, the Warning Letter is available on the FDA website.