Lupin announces resolution of USFDA warning letter for its two facilities
This is after the satisfactory evaluation of the corrective actions taken by the company in response to the warning letter that…
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Browsing Tag
Warning Letter
US FDA issues warning letter to Lupin for Maharashtra-based API plant
The FDA inspected the manufacturing facility from 22nd March to 4th April, 2022
Aurobindo Pharma receives Sebi’s warning letter over ongoing US FDA audit
The letter is in regards to certain disclosures made by the company on the ongoing FDA audit of company's Unit-I and observations…
Aurobindo Pharma gets warning letter from US FDA for API facility
The action follows the recent inspection of the facility by the US Food and Drug Administration (FDA) in August 2021, the…
Lupin gets warning letter from US FDA for Somerset facility
The US FDA had inspected the Lupin Somerset site from September 10, 2020, to November 5, 2020
US FDA issues warning letter to Shilpa Medicare for Jadcherla facility, Telangana
The company believes that the warning letter will have minimum impact of disruption of supplies and the existing revenues from…
Panacea Biotec gets warning letter from US FDA for Baddi facility
The company informs that it is in the process of providing a thorough and comprehensive response to the USFDA within the statutory…
US FDA issues warning letter to Glenmark for its Baddi facility
US FDA had inspected the facility between April 15 and April 20 and earlier classified the inspection as an official action…
Lupin gets warning letter from US FDA for Mandideep facility
Lupin said there are no drug master file and abbreviated new drug applications (ANDA) pending review or approval from the…
Indoco’s Goa Plant I receives Warning Letter from US FDA
The facility had received six observations in Form 483s and was classified as ‘OAI’ (Official Action Indicated’) in March 2019