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API Manufacturer Flagged for Quality, Investigational Issues
Drugs Inspections and Audits
The FDA cited API manufacturer CIL Isotope Separations after an inspection of its Xenia, Ohio facility revealed quality control issues, investigational deficiencies and other violations.
The firm’s quality control unit failed to conduct investigations or test incoming materials and the unit was not separated from other departments, according to the Form 483 report.
Lots that failed microbial and endotoxin tests were not investigated, and an oxygen-18 finished product sample’s initial out of specification result was not looked into, the agency said.