FDA warning letters detail issues for manufacturing sites in the US and India
The FDA this week released new warning letters for drug manufacturers in the US and India following the discovery of several quality issues.
One warning letter was handed to Fort Worth, TX-based Sovereign Pharmaceuticals last month which detailed that the site had “failed to validate the manufacturing process” for an undisclosed tablet, as some of the active ingredients were out-of-specification.
While Sovereign claimed that it launched an investigation into the matter, the FDA felt that its response was not sufficient.
“Your firm did not provide sufficient data to show where variability in your process was occurring. Your manufacturing process failures indicate that you do not have an adequate ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality,” the letter said.
The FDA also saw during its initial observations that the site’s quality unit was not “effectively exercising its responsibilities to oversee the quality of your drug manufacturing operations,” as written procedures were not being followed.
“You failed to provide sufficient data to show that your stability samples were not negatively impacted by the excursions listed in the observation. In addition, you did not perform a retrospective review for other potential similar excursions to take appropriate CAPAs and product impact evaluations. You also failed to perform a comprehensive review of similarly impacted systems by a deficient QU,” the letter said.
India-based generics giant Lupin was also hit with a warning letter for its plant in Tarapur, India, with the letter unveiling that the company had not established written procedures for cleaning equipment for manufacturing APIs.
Lupin had notified the Indian stock exchange of the letter in early October.
FDA revealed that Lupin also didn’t have written procedures to monitor the progress of “processing steps” that may cause “variability” in the quality of the ingredients as well as not properly investigating all “critical deviations.”
According to the letter, the company had suspended the production of drugs for the US market and must notify the FDA if it wants to restart making drugs for the US.
Both companies had 15 days to respond to the FDA or risk further penalties.
