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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