Tell me, doctor
What results do we want this time?
Purity of 50, or 99.99%?
All I wanted to do was make my compounds and cha-ching!*
From our friends at the Center for Drug Evaluation and Research, a real gem of a 483 for API manufacturer Tai Heng Industry, located in Shanghai, China:
2. Failure to prevent unauthorized access or changes to data, and to provide adequate controls to prevent manipulation and omission of data.
During the inspection, an FDA investigator discovered a lack of basic laboratory controls to prevent changes to your firm’s electronically stored data and paper records. Your firm relied on incomplete records to evaluate the quality of your drugs and to determine whether your drugs conformed with established specifications and standards.Oh, the FDA inspectors will never notice that!
Our investigator found that your firm routinely re-tested samples without justification, and deleted analytical data. We observed systemic data manipulation across your facility, including actions taken by multiple analysts and on multiple pieces of testing equipment.
Specifically, your Quality Control (QC) analysts used administrator privileges and passwords to manipulate your high performance liquid chromatography (HPLC) computer clock to alter the recorded chronology of laboratory testing events.
*with apologies to Huey Lewis and the News.