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Home » Topics » Pharmaceuticals » GMPs

GMPs
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Chinese Drugmaker Lands Warning Letter for Data Mishandling

August 18, 2016
The FDA has faulted an API maker for a host of failings at its production facility in China, including tampering with official records. Read More

German Regulators Find 35 Issues With Lab in India

August 15, 2016
Regulators in Germany have cited a lab in India with litany of GMP violations and have recommended a prohibition of supply. Read More

NIH Permanently Stops Production at Site Scrutinized by FDA

August 11, 2016
Development site had been decommissioned due to significant GMP violations. Read More

ASP Criticized for Compounding Drugs Without Approval

August 8, 2016
Company cited for producing misbranded and adulterated drugs at facility. Read More

Warning Letter Faults Chinese Firm for Data Mishandling

August 8, 2016
FDA cited Xiamen Origin for three primary deficiencies found at Fujian facility. Read More

EU Urged to Suspend License of Chinese API Maker

August 5, 2016
Company has been in violation of GMP standards since June 2015. Read More

FDA Warns Compounder Over Lack of Prescriptions, Adulterated Products

August 2, 2016
A compounding operation in Texas has landed an FDA warning letter for compounding drugs without prescriptions and for sterility concerns. Read More

FDA Parcels Out Warning Letter for Data Mishandling

August 2, 2016
The FDA has faulted an API maker for a host of failings at its production facility in China, including tampering with official records. Read More

Valeant Receives CRL Due to GMP Inadequacies

August 2, 2016
FDA rejection was for Bausch + Lomb’s division’s eye solution. Read More

EU Regulators Push for Suspension of Chinese API Maker’s License

August 1, 2016
Spanish regulators are recommending that EU officials suspend a manufacturing certificate from a Chinese API maker over repeated issues at its plant. Read More

FDA Hands Two API Makers 483s for Deficient Procedural Systems

August 1, 2016
Two U.S. API makers are taking heat for a host of recordkeeping failures and related issues following FDA inspections of their production facilities. Read More

FDA Rejects Valeant Eye Solution Due to GMP Deficiencies

July 28, 2016
GMP deficiencies are unrelated to efficacy and safety concerns. Read More
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