St. Louis-based API manufacturer slammed with FDA warning letter over 'pervasive mold,' quality issues
The growth of API manufacturing in India and China has led to numerous warning letters and lots of question marks around quality control and data integrity issues. But violations by US-based API manufacturers can be just as questionable.
For instance, in a warning letter dated last week, St. Louis-based API manufacturer Jost Chemical was critiqued for the way it failed to adequately respond to mold contamination, following complaints from August 2018 related to its manufacture of potassium sulfate.
“Notably, you reported that approximately 83 percent of your microbial product failures were mold-related failures,” FDA noted, explaining that the site’s water systems are not adequate, especially as the site manufactures APIs that are used by customers to produce sterile drug products.
“Your current frequency of testing and water quality standards are inadequate to ensure control over your manufacturing processes,” the warning says. “You are responsible for ensuring the water for equipment cleaning and manufacturing is of suitable quality and does not potentially contribute to contamination of microbes or microbial byproducts to API processes.”
What’s more is that the company did not recall the APIs affected by mold.
“You did not initiate a formal recall with FDA notification but instead informed your clients the lots failed to meet specifications and instructed them to return or destroy the failing lots,” the FDA said. “In addition, your retests showed pervasive mold in three lots, but you did not expand your investigation sufficiently to include other potentially impacted lots to fully address the scope of the problem.”
Now, the FDA wants Jost to do a retrospective review of out-of-spec results it initiated over the last three years to identify investigations that were not expanded to include all potentially impacted lots.
And like some of its Chinese and Indian API counterparts, the FDA also warned Jost for insufficient controls over its cGMP data. Not only does Jost lack unique passwords for lab instruments used to generate analytical data for finished API products, but the inspection found that the site’s analytical systems lacked controls to prevent users from deleting electronic data — a major issue.
The site also lacks procedures governing the review of audit trails of both production and laboratory equipment, and the FDA also found its cleaning validation for non-dedicated manufacturing equipment is inadequate, and its microbial test procedure is inadequate.