US FDA wants evidence Opto-Pharm's Tuas plant remediation effort has worked

The US food and Drug Administration (FDA) detailed its concerns about Opto-Pharm’s remediation plan in a letter​ this week.

Foremost among the criticisms is that Opto-Pharm did not seek approval for two eyewash products - Buffered Eye & Skin Xpect and Buffered Eye & Skin First Aid Direct - that are defined as over-the-counter (OTC) drugs under US law.  

The agency said: “We are not aware of sufficient evidence to show Buffered Eye & Skin Xpect and Buffered Eye & Skin First Aid Direct, as formulated and labelled, are generally recognized as safe and effective

Tuas plant problems​

The agency also criticised Opto-Pharm’s efforts to make its Tuas facility compliant, asserting that it has not provided evidence to show its work to correct problems identified during an inspection last March have been effective.

In particular, the FDA said Opto-Pharm has not demonstrated the efficacy of microbial control measures introduced at the Tuas plant in response to the inspection.

The FDA also said the firm has not established whether data supplied by its container closure supplier is reliable, despite committing to sending samples to an external laboratory and periodically assess its supplier.

The agency said Opto-Pharma must “provide your supplier evaluations and a summary of laboratory test results relating to all of the components, containers, and closures you use to manufacture your sterile drug products​.”