CDER Warns Three OTC Drugmakers in China, Germany and Mexico

Regulatory NewsRegulatory News | 28 January 2020 |  By 

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Tuesday released three warning letters sent to China-based over-the-counter (OTC) drugmaker Sunstar Guangzhou Ltd., Dresden, Germany-based Dental-Kosmetik GmbH & Co. and Tijuana, Mexico-based Baja Fur S.A. de C.V.

For Sunstar Guangzhou, FDA noted following its five-day inspection last June that the company released certain OTC drugs without conducting identity and strength testing. The firm was placed on import alert on 21 January.

FDA also said the company failed to test incoming components used to manufacture its drugs and raised further questions about the firm’s microbiological testing.

“Uncontrolled copies of manufacturing batch records and in-process control forms were pre-printed and kept in a room with unrestricted access,” the warning letter noted.

Dental-Kosmetik GmbH & Co.

For the German firm, which was placed on import alert on 10 January, FDA found that it failed to adequately validate the processes used to manufacture its drugs.

FDA explained, following a five-day inspection last July, how the firm had to significantly deviate from its batch manufacturing to achieve passing results, noting that when products do not meet quality requirements, one of the firm’s procedures allows for repeat testing and adjustments until passing results are achieved.

“Your firm does not have an adequate stability testing program to demonstrate that the chemical and microbiological characteristics of your over-the-counter drug products remain acceptable throughout their labeled expiry period,” the letter noted.

Baja Fur S.A. de C.V.

Following a five-day inspection last July, CDER in December sent the firm a warning letter after finding that it failed to adequately investigate the out-of-specification (OOS) microbiological contamination that caused it to reject batches of an unidentified OTC drug.

“While you documented these OOS results in your annual product review, you failed to conduct an adequate investigation to prevent recurrence or microbial contamination in the drug products you manufacture for the U.S. market,” FDA said.

The agency also noted that the firm’s batch records do not include adequate production details, including the steps in filling operations and the person(s) performing each significant step.

Sunstar Guangzhou Ltd.

Dental-Kosmetik GmbH & Co. KG

Baja Fur S.A. de C.V.


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