The OAI classification implies that the US FDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved
The inspection concluded with four Form 483 observations. None of the observations were related to data integrity.
The company has responded to the warning letter and carried out the committed corrections.
Syngene's collaboration with Zoetis started in 2011
The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated
The company has been issued a Form 483 with two observations which the company will address within the stipulated timeline.
This integrated, multi-product facility houses manufacturing suites, analytical testing laboratories and warehousing.
U.S. FDA has issued Form 483 with six observations after an inspection of the company’s formulation manufacturing facility based out of Baddi
The US FDA had conducted an inspection of Alkem Laboratories Limited's manufacturing facility located at St. Louis, USA.
Both manufacturing facilities are based out of Benguluru, India
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