U.S. FDA Issues Warning Letter To Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA)’s Over Manufacturing Plant In China

The U.S. Food and Drug Administration (FDA) have flagged concerns over the mechanized controls at Teva’s Pharmaceutical industries Ltd (NYSE:TEVA) facility in China. The FDA has issued the company with a warning letter on April 10 following a regulatory inspection carried out at the plant in September last year.

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Teva, the Israel’s largest firm in China said that they are in the process of addressing concerns as raised by the agency and will respond to them by May 1. The FDA referenced several deficiencies at Teva’s active pharmaceutical plant regarding their production controls and sampling techniques and processes.

Teva’s spokesperson said that the company strictly follows and adheres to the highest quality and compliance standards in their manufacturing plant and that the concerns would not deter or interrupt the processes at the facility. Therefore, there will be no shortage in the supply of the company products to their patients.

The Israel-based drug company Teva, has had issues with the agency since last year that has largely affected their operations. According to the latest news, the company has received two warning letters in just six months. In October last year, the FDA flagged more concerns on Teva’s sterile injectables facility in Hungary citing several important sterility issues at the plant. The agency had earlier prohibited the facility from shipping its products to the United States.

The newest allegations adds injury to the already struggling company which has recently been planning to lay off more than 6000 employees to cut down the operational costs experienced in the company. The company has also significantly been trying to reduce costs of about $40.5 billion takeover of Allergan’s generic drug production in the last year.

The recent concerns about the company will impact on the performance of the company and may severely bring down its operations that could lead to closure of its several branches across the globe. The company shares have slumped steadily since last year and this could worsen if the concerns raised by the FDA agency are not resolved immediately.

After declining $0.05 or 0.16%, Teva closed yesterday’s trading session at $32.06.

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