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

By Staff Reporter

- Last updated on GMT


Related tags Food and drug administration Over-the-counter drug

The US FDA has criticised Opto-Pharm Pte for selling unlicensed "drugs" and not bringing its Singapore manufacturing plant up to code.

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​.”

Related news

Show more

Related product

Understanding the hidden value of quality

Understanding the hidden value of quality

Content provided by Thermo Fisher Scientific – Production Chemicals and Services | 16-Jan-2023 | White Paper

The raw material supply is too vital to leave to chance, and quality-related supply chain activities are cornerstones to your success.

Follow us


View more