Regulatory Focus™ > News Articles > 3 > FDA Warns OTC Drugmakers in China and Hong Kong, Sends 483s to Aurobindo and Sun

FDA Warns OTC Drugmakers in China and Hong Kong, Sends 483s to Aurobindo and Sun

Posted 06 March 2018 | By Michael Mezher 

FDA Warns OTC Drugmakers in China and Hong Kong, Sends 483s to Aurobindo and Sun

The US Food and Drug Administration (FDA) on Tuesday released warning letters sent to two over-the-counter (OTC) drugmakers in China and Hong Kong, as well as two Form 483s for India-based Sun Pharmaceutical Industries and Aurobindo Pharma.

Zhejiang Ludao Technology

In a warning letter to Taizhou, China-based over-the-counter (OTC) drugmaker Zhejiang Ludao Technology Co., Ltd., FDA cites the company for data integrity and product testing issues.

"Your firm lacks basic laboratory controls to prevent changes to paper and electronic records," FDA writes, noting that the company admitted to creating certificates of analysis (COA) for four batches of OTC products before the products were manufactured.

FDA said it also found computer files in the recycle bin for the company's stand-alone high-performance liquid chromatography (HPLC) system. According to FDA, the system did not have audit trail capabilities and the company could not explain why the files were deleted.

Prior to the inspection, FDA detained and tested samples from a batch of an OTC spray made by Zhejiang Ludao that had nearly twice the amount of active ingredient specified on the label. According to the agency, the company has agreed to reformulate the spray and update its test methods to conform to the corresponding USP monograph.

Nan San Pharmaceutical

In a warning letter to Hong Kong-based OTC drugmaker Nan San Pharmaceutical Factory Limited, FDA says the company failed to conduct adequate laboratory testing and marketed misbranded products to the US.

The warning letter comes after FDA inspected the company's facility in Kwun Tong Kowloon, Hong Kong in late September. As a result of the inspection findings, FDA placed the firm on import alert in January.

According to FDA, Nan San failed to perform microbial limit tests for each batch of one of its products from 2013 to 2016.

"Instead, you performed microbial limit testing on one batch in 2013, and reported the same results to release subsequently-manufactured batches to the United States," FDA writes.

And FDA says the company set expiration dates for some of its products without adequately assessing the products' stability characteristics.

FDA also says that two of the company's OTC products, Musflex and Easy-Flex, are misbranded as their labels do not declare their active or inactive ingredients.

Form 483s

The Form 483 for Aurobindo included nine observations following a seven-day inspection last month, with FDA’s investigators observing dirt build-ups “with potential quality impact on the drug product.”

Sun Pharmaceutical Industries’ Form 483 included three observations from a 12-day inspection, including issues with cleaning and maintenance.

Warning Letters: Nan San Pharmaceutical, Zhejiang Ludao Technology

Form 483: Sun Pharmaceutical, Aurobindo Pharma

Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.