The FDA has cited International Isotopes ($INIS) for 6 GMP violations in Warning Letter SEA 12-03, issued Oct. 26 and just posted to the agency's website. The Idaho Falls, ID-based company supplies radiopharmaceutical sodium iodide I-131 solution.
Among the 6 violations are failure to conduct an identity test of incoming materials, failure to calibrate instruments, and lack of controls to ensure the integrity of materials and manufacturing data stored in computer systems. The warning letter also cites the company for unapproved new drug violations in addition to the manufacturing violations.
The company requested a July inspection "to clearly establish our status as a registered FDA facility for the re-packaging and distribution of an active pharmaceutical ingredient," CEO Steve Laflin said in an email. He added INIS is "taking this opportunity to improve our manufacturing processes in complete accordance with current Good Manufacturing Practices."
After receiving the FDA's Form 483 inspection observations report in July, INIS filed a response in August--within the requisite 15 working days. But the agency ruled the response contained insufficient corrective actions, according to the warning letter. INIS responded again in mid-September with additional details; however, the regulator didn't consider the second response prior to issuing the warning letter because it was received after the initial 15-day deadline.
"INIS has in fact provided two subsequent responses to the FDA inspection, providing them with continuous updates on our progress in implementing appropriate corrective measures," according to Laflin. "All of these responses will again be supplied to the FDA in response to the [warning] letter."
-here's Warning Letter SEA 12-03