Yungshin through the U.S. FDA factory inspection, new products sold in the U.S
[2023-09-07]
Yungshin Pharmaceuticals (1716) announced that it again passed FDA inspection with a loss of 0483. Upon completion of this inspection, the company will continue to sell its products in the United States and will be commissioned by Impax and pharmaceutical companies in the United States. Additional products will also be available for sale in the United States market, the company's export performance is also expected to have significant growth opportunities.
Form 483 is to indicate that the FDA plant inspection personnel log shortcomings, the need to select specific improvement after the FDA review.
The company said the inspection was the toughest challenge it had ever faced. FDA officials inspected 18 plants in 2009, and 15 were issued Form 483, more world-class big pharmaceutical companies have been sent Warring letters. The FDA official used a variety of unique verification techniques to verify the consistency and control of the plant's production processes over a five-day period, culminating in a wrap-up meeting in which No 483 was missing to confirm the company under review. During the five-day review, FDA officials used the words “Great Company, Great People” to confirm that Yungshin and the team under investigation had met international standards in GMP and indeed prepared Yungshin for the global vision of the Company.
Form 483 is to indicate that the FDA plant inspection personnel log shortcomings, the need to select specific improvement after the FDA review.
The company said the inspection was the toughest challenge it had ever faced. FDA officials inspected 18 plants in 2009, and 15 were issued Form 483, more world-class big pharmaceutical companies have been sent Warring letters. The FDA official used a variety of unique verification techniques to verify the consistency and control of the plant's production processes over a five-day period, culminating in a wrap-up meeting in which No 483 was missing to confirm the company under review. During the five-day review, FDA officials used the words “Great Company, Great People” to confirm that Yungshin and the team under investigation had met international standards in GMP and indeed prepared Yungshin for the global vision of the Company.