The FDA has slammed a Shanghai API maker in a warning letter for what it called “systemic data manipulation” which raised questions about the quality of the Chinese company’s products.
FDA inspectors were in the Tai Heng Industry plant in May 2015, according to the warning letter, which the FDA issued earlier this month and posted this week.
Inspectors said that batch samples were routinely retested following failing or atypical results until acceptable results were obtained, and the failures were never investigated to determine their cause. When the retesting was done, quality-control analysts would then use administrator privileges and passwords from unprotected equipment to manipulate results on the high performance liquid chromatography (HPLC) computer.
On top of that, operators used “mock” sheets to capture critical manufacturing data, then backdated batch production records days after operations ended, the warning letter said.
The FDA was not satisfied with the company’s pledge to have a third-party company audit its quality systems. It said it also wanted a complete investigation into the data manipulation and reports on potential effects on products. And it wants Tai Heng to figure out why it was getting out-of-spec results and then fix the problems, not cover them up.
The letter to Tai Heng was one of two the FDA posted this week. The agency also found a list of faults at a Baesweiler, Germany, API plant operated by BBT Biotech. It said the company has shipped APIs to the U.S. since 2012 without ever doing stability testing to support the expiration dates it put on its products and was not adequately investigating out-of-spec issues.
- read the warning letter
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