Correction: A previous version of this article indicated Shanghai Desano Chemical Pharmaceutical supplied dolutegravir to ViiV Healthcare. ViiV said Desano had no involvement in the supply of dolutegravir or any dolutegravir-based treatments currently marketed.
- The Food and Drug Administration has warned two Chinese drugmakers of manufacturing lapses, citing Shanghai Desano Chemical Pharmaceutical and Chongqing Lummy Pharmaceutical for data irregularities and manipulation.
- A May 2015 inspection found Shanghai Desano, which works with GlaxoSmithKline's Viiv Healthcare, had conducted about 8,400 unofficial chromatographic analyses between 2012 and 2014. Desano indicated that some of these unofficial analyses were indeed out-of-specification.
- The Food and Drug Administration also warned Chongqing Lummy over extensive data manipulation, including setting computer clocks back to make tests appear as if they had been conducted earlier.
Violations of data security and quality control standards are recurring problems for Chinese manufacturers cited by the FDA, frequently turning up in the warning letters sent to inform drugmakers when they are out of compliance.
The FDA has stepped up its oversight of foreign drug manufacturers, both in China and in India. There are currently 52 Chinese suppliers listed on the FDA's import ban list, along with 42 Indian firms.
In the FDA's inspection of Chongqing Lummy's facility, investigators found evidence of several major laboratory control violations. In one case, an analyst had set a gas chromatography clock back in order to make it appear tests had been conducted seven months earlier. Lummy's quality unit then used this falsified data to evaluate the quality of the active pharmaceutical ingredient. The FDA investigator found this was done for at least five other API lots.
Shanghai Desano also struggled to adequately ensure the integrity of its data. Approximately 8,400 unofficial chromatographic analyses were conducted between 2012 and 2014 and stored outside of official quality control records.
The FDA indicated it believed the practice was standard procedure at Desano's facility, given the volume of unofficial data.
A spokesperson for ViiV Healthcare said the company had conducted an internal review of the potential implications from the FDA's warning to Desano.
"We can confirm that we don’t expect any supply issue as a result of this for any of the ViiV Healthcare products," the spokesperson said.
As it typically does, the FDA warned it could block imports of products from Lummy or Desano if either firm failed to correct the violations outlined in the letters.