FDA Warns Three OTC Drugmakers in UK, Hong Kong and Korea

Regulatory NewsRegulatory News | 17 April 2018 |  By 

The three warning letters released by the US Food and Drug Administration (FDA) on Tuesday were sent in the last month to over-the-counter (OTC) drug manufacturers including UK-based McCallum Manufacturing, Hong Kong-based Luen Wah Medicine Ltd. and Korea-based Hanbul Cosmetics Co., Ltd.

For McCallum, FDA said the firm lacked a quality control unit and released OTC drug products without testing incoming raw materials, or testing for the product’s identity and strength.

And though McCallum said it was too small and did not have the resources for a quality unit, FDA noted:
“Regardless of the size of your company, as a drug manufacturer, you must have a quality unit that is responsible for and authorized to perform certain operations.”

Similarly, Luen Wah Medicine was also cited for not testing the identity and strength of each active ingredient and for releasing products to the US “without testing for total aerobic microbial count and objectionable micro-organisms.”

The Hong Kong company also has not validated the processes used to manufacture its drug products and “relied solely on certificates of analysis (COA) from unqualified suppliers.”

Korea-based Hanbul, meanwhile, could not provide FDA with raw data to verify that it performed microbiological finished product testing. The firm’s batch records also “do not include significant production details, including but not limited to weights and measurements of raw materials used in the manufacturing process,” the warning letter said.

McCallum Manufacturing Ltd 4/9/18

Luen Wah (HK) Medicine Ltd 4/6/18

Hanbul Cosmetics Co., Ltd 3/29/18


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