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Case study of FDA warning letters Muhammad Asim Niazi
January 23, 2024
A warning letter is a part of communication by the FDA with the manufacturer to share their finding to remove the discrepancy found during their inspection and inform the status of the manufacturer's measures.
Lupin gets warning letter from US FDA for Somerset facility expresspharma
June 16, 2021
The US FDA had inspected the Lupin Somerset site from September 10, 2020, to November 5, 2020.
Nephron Receives Warning Letter from FDA americanpharmaceuticalreview
October 12, 2020
The U.S. Food and Drug Administration (FDA) has issued a warning letter to Nephron Pharmaceuticals Corporation due to emails Nephron’s CEO and a sales representative sent concerning its product Budesonide Inhalation Suspension ...
US FDA issues warning letter to Shilpa Medicare for Jadcherla facility, Telangana expresspharma
October 12, 2020
The company believes that the warning letter will have minimum impact of disruption of supplies and the existing revenues from operations of this facility.
Indian drug manufacturing facility issued FDA warning letter europeanpharmaceuticalreview
March 26, 2020
Windlas Healthcare Private Ltd has been sent a warning letter by the FDA for violations of current good manufacturing practice regulations.
FDA and FTC issue warning letters to companies selling fraudulent COVID-19 products europeanpharmaceuticalreview
March 11, 2020
The US agencies have issued letters to seven companies, and removed online listings from others, whose products falsely claim to prevent or treat coronavirus.
FDA sends warning letter to KVK-Tech manufacturing facility europeanpharmaceuticalreview
March 03, 2020
A warning letter has been sent by the US FDA to KVK-Tech regarding cGMP violations at their drug manufacturing site, including for data integrity.
FDA issues warning letter to Health Pharma for cGMP violations europeanpharmaceuticalreview
January 17, 2020
An inspection at a manufacturing facility belonging to Health Pharma has revealed breaches of cGMP regulations, causing the FDA to send a warning letter.
FDA issues warning letter which highlights the importance of a quality unit europeanpharmaceuticalreview
January 07, 2020
Henan Kangdi Medical Devices Co Ltd has been sent a warner letter after an inspection found cGMP violations that included failures of the company’s quality unit.
FDA Issues Warning Letter to Alkermes americanpharmaceuticalreview
December 19, 2019
The U.S. Food and Drug Administration (FDA) posted a warning letter to Alkermes of Massachusetts, for misbranding the drug Vivitrol (an extended-release injection formulation ...