The observations primarily relate to the need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications & computerized tools
The unit has filed 2 Derma products and 1 MDI product.
The company has received 1 (ONE) observation on Form 483 with respect to ANDA filed for the product to be manufactured at the said Facility.
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.
The audit is part of the agency's inspection for three product applications filed and slated to be manufactured at this site.
The company has been issued a Form 483 with two observations which the company will address within the stipulated timeline.
This GMP and Pre-Approval Inspection is part of the routine business operations and the company shall submit to US FDA within the stipulated timeline
The company has received 2 observations on FDA Form 483 with respect to ANDA filed for the product to be manufactured at Indore plant.
The company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe.
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