The US FDA warned Taiwan-based Drug manufacturer, Vida International following an inspection at Taoyuan city facility last December over GMP non-compliance and placed Vida on import alert in March. In the warning letter, the US FDA states that Vida has not conducted batch testing for one of its products before release.
FDA wrote, “You released an OTC drug to the US market without testing its identity, strength, purity and critical microbial attributes before release”.
The US FDA says the firm failed to test incoming raw material (including the API), prepared an inaccurate batch record for a lot of one of its drugs (formula and ingredients differs from the label) and failed to establish a well-equipped Quality Control Unit.
Vida provided a response, but FDA deemed it inappropriate and requested the company to provide plan for testing samples of all batches and implement Quality Risk Management system for all products.
Furthermore, the US FDA state that the company must put in place corrective and preventive action (CAPA) plans to address deficiencies in its stability program and Quality Control Unit and provide information on test methods and specifications before resuming manufacturing drugs at the facility for US market.
Mr Vinod Arora, Principal Advisor, IGMPI
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