The FDA has sent a warning letter to International Isotopes, a radiochemical product manufacturer based in Idaho Falls, Idaho, due to violations of Current Good Manufacturing Practice regulations.
In the letter dated October 26, addressed to International Isotopes president and CEO, Stephen T. Laflin, and written by FDA district director, Charles M. Breen, a number of violations in the production of Sodium Iodide I-131 solution discovered during a July inspection were outlined, including:
- All appropriate identity tests were not performed on each batch of incoming components;
- There was no established written procedure for the calibration of pipettes, scales and radioisotope calibrators used in the manufacture of Sodium Iodide I-131;
- Software used in batch production had not been validated; and
- Written procedures for storage, handling, labeling and a number of other processes lacked sufficient detail.
In addition, the letter said International Isotopes was manufacturing Sodium Iodide I-131 solution, classified as a “new drug,” without an approved application from the FDA. Despite not having the application on file, the FDA will allow continued production of the solution while the manufacturer corrects the violations.
“This decision is consistent with FDA’s commitment to take action against marketed unapproved drugs without imposing an undue burden on patients,” wrote Breen.
International Isotopes had previously responded to the inspection observations in August, but the response lacked sufficient corrective actions, according to the warning letter. The firm has 15 days from receipt of the warning letter to notify the FDA of actions taken to correct the violations.