US FDA warns Taiwan OTC maker over manufacturing violations

By Flora Southey

- Last updated on GMT


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

Failure to test ingredients’ identity in an over-the-counter drug product is one of the violations that landed Polaroisin International a US FDA warning letter.

The US Food and Drug Administration (FDA) issued the warning letter​ to the Taiwan-headquartered firm following an inspection of its manufacturing facility in Taipei City from September 11 to 15, 2017.

According to the FDA, Polaroisin released a finished over-the-counter (OTC) drug product without testing for the identity of active ingredients and excipients.

The FDA said the firm’s reply – received on October 6, 2017 – was unsatisfactory.

“Your response does not specify how you will conduct assay analysis to verify the strength and identity of your OTC drug product prior to release,” ​said the Administration.

The FDA told the firm to “commit to testing each incoming lot of raw materials for identity.”

Further, Polaroisin lacked an ongoing control monitoring programme to ensure consistent drug quality, said the FDA.

“In your response, you stated that you need additional time to develop training for your employees,” ​said the Agency.

“Your response is inadequate as you failed to address your lack of process validation prior to distribution of drugs and your lack of a plan to validate your manufacturing process,” ​it added.

“Drugs, not cosmetics”

According to the Agency, the firm also said it plans to follow the “cosmetics production standard​” when making the OTC drug product.

“If you market your OTC drug product in the US, this drug product must be manufactured in accordance with cGMP standards for drugs, not cosmetics,” ​said the Agency.

The FDA placed Polaroisin on Import Alert 66-40​ on January 8, 2018, and advised the firm seek advice from a consultant to “assist your firm in meeting drug cGMP requirements.” 

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