In the letter the US drug regulator raised concerns about the facility in Pomezia, citing an audit conducted in December.
The agency said investigators had identified deficiencies in smoke studies and witnessed operators performing “manually intensive aseptic activities,” which it said could pose a significant contamination hazard.
The FDA said Tubilux must “Identify all contamination hazards, including with respect to your aseptic processes, equipment, and facilities” adding that “the risk assessment should fully evaluate the microbiological contamination risks throughout your operation.”
The agency called on the firm to submit a comprehensive corrective action and preventive action (CAPA) plan that details and tracks planned remediation efforts.
The FDA also said Tubilux needs to address the “need for particle testing of finished products” and specify how it will assess the ophthalmic products, gels and medicated eye drops made at the site.
Tubilux did not respond to a request for comment.