Warning Letter and Import Alert for Chinese Manufacturer
During an FDA inspection of a Chinese drug manufacturer, the inspector criticized serious and sometimes even bizarre GMP violations Read more about the Warning Letter to the Chinese Manufacturer Baoying County Fukang Medical Appliance Co. Ltd.
Serious Violations of GMP and Obstruction to an Inspection: FDA Warning Letter for a Chinese API Manufacturer
At companies where serious GMP violations are observed, a misconduct of the personnel can often be identified during the inspection. A Warning Letter issued to a Chinese API manufacturer describes attempts to obstruct the inspection as well as some typical violations of GMP with regard to data integrity.
In November, 2014, we had reported about the FDA guideline "Guidance for Industry: Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection". This guideline determines how the FDA handles companies that delay, restrict or refuse an inspection or deny access to individual rooms respectively refuse the entire inspection. A current Warning Letter demonstrates the significance of this guideline.
Comprehensive Data Manipulation: New FDA Warning Letter for European Medicinal Product Manufacturer
An inadequate access control to the data processing of analytical chromatographic system means in all cases that data can be manipulated. A Warning Letter recently published gives an impressive example of insufficient data integrity in the area of quality control.
Is Cost Pressure becoming the Main Reason for GMP Non-Compliance and Drug Shortages?
It has been a hot inspection summer. FDA Warning Letters and EU Non-Compliance Reports seem to increase at the moment. It is worrying that the GMP non-compliance issues apparently get more serious than in the past. But what is the reason for the increasing GMP non-compliances?
EudraGMDP is the European Database for GMP and GDP Compliance information. The database receives a lot of attention from industry because of the GMP and GDP Non-Compliance Reports. Now, the database has been changed without notice and has caused some confusion. Read more about the updated EudraGMDP Database.
FDA Warning Letter to pharmaceutical manufacturer in Taiwan who owns ISO Certificates
Asia has been in the centre of attention when it comes to GMP non-compliance. This time the company KO DA Pharmaceuticals Co has been inspected by FDA and received a Warning Letter. Read more about the FDA Warning Letter here.