Carbogen Amcis completes Swissmedic inspection of its facility in Vionnaz, Switzerland
This inspection continues a series of successful inspections by Swissmedic in Vionnaz with the first inspection in 2015 followed by 2016, 2017 and 2020.
This inspection continues a series of successful inspections by Swissmedic in Vionnaz with the first inspection in 2015 followed by 2016, 2017 and 2020.
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 audit is part of the agency's inspection for three product applications filed and slated to be manufactured at this site.
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.
He will be responsible for ensuring that every dose of medication that ACG Inspection’s pharmaceutical and nutraceutical partners provide is manufactured and delivered exactly as intended
The inspection was triggered by Shilpa's submission of applications for four ANDA's to seek approval to use this site as an alternate testing laboratory
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