The FDA served a warning letter to China’s Wuxi Medical Instrument Factory in response to an inspection that exposed four violations, including an infringement on procedures that involved company employees misrepresenting to inspectors the actual dates of the creation of some documents.
The inspection at the Wuxi City-based facility took place in early March.
During the inspection, the agency said in a letter to the company posted on its website this week, the FDA found that records covering January to March of this year were signed by two employees that stated sanitization had been completed and verified contemporaneously during those months.
“However, our investigator found that these operations were not documented at the time of their actual performance, but were instead created and completed on March 7, 2017, the second day of the inspection," the letter said.
The regulatory agency also said it found Wuxi Medical Instrument Factory was unable to provide process qualification batch records and quality control test documentation, and only gave inspectors "a protocol and a summary report with insufficient data.”