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Galaxy Surfactants receives 13 observations from USFDA, for Tarapur unit

Galaxy Surfactants has received Form 483, for two of its facilities situated at Tarapur, Maharashtra.

The company’s two of the facilities (M3 & N46) at Tarapur have undergone United States Food and Drug Administration (USFDA) inspection, which was concluded on March 30, 2018. Post-inspection the M3 facility received 4 observations and N46 facility received 9 observations.

In a release the company stated that, all observations are procedural in nature and none of them are related to data integrity. The company will be providing a comprehensive response to the observations, within a stipulated time. Further, these facilities manufacture two products, Octyl Methoxy Cinnamate and Octocrylene, which have USP monograph.

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