Regulatory action – Isologic Innovative Radiopharmaceuticals Ltd.

Under the Nuclear Safety and Control Act and associated regulations, various levels of regulatory action can be taken by the Canadian Nuclear Safety Commission (CNSC) to protect the health, safety and security of Canadians and the environment.

2017

May 4, 2017

Order to Isologic Innovative Radiopharmaceuticals Ltd.

On June 28, 2016, the CNSC notified Isologic Innovative Radiopharmaceuticals Ltd. that it would no longer be authorized to conduct servicing activities on Class II prescribed equipment as of July 1, 2016.

The CNSC had sent multiple notifications reminding the licensee of the imminent expiry of servicing licence 15012-3-16.1 for their cyclotron facilities.

Isologic Innovative Radiopharmaceuticals Ltd. was made aware on multiple occasions of the four-week licence application processing time. An application to renew their licence was submitted on the date of expiry of the previous licence. Servicing activities remained prohibited pending review of the application and issuance of a new licence.

During the assessment of the application, a request for information was sent to the applicant (July 20, 2016) with regard to servicing activities for their cyclotron facilities. On August 18, 2016, the applicant indicated that all servicing was conducted by a licenced third-party service provider.

The CNSC visited Isologic’s Lachine, Quebec site on August 24, 2016, where inspectors discovered that Isologic staff had in fact participated in servicing activities that they were no longer authorized to perform during the licence renewal period, contrary to the information submitted by the applicant. Consequently, Isologic was immediately issued an order to cease and desist from all such servicing activities.

The licensee immediately complied with the order, and promptly submitted an addendum to their service licence renewal application which provided an acceptable basis for renewal of the licence. A new Class II prescribed equipment servicing licence was issued on August 29, 2016, and the order was closed.

Read the order (PDF)

2015

March 3, 2015

Update on the administrative monetary penalty (AMP) issued to Isologic Innovative Radiopharmaceuticals Ltd.

On March 3, 2015, the CNSC confirmed that the AMP issued to Isologic Innovative Radiopharmaceuticals Ltd. has been paid. The CNSC now considers this AMP closed.

February 6, 2015

AMP issued to Isologic Innovative Radiopharmaceuticals Ltd.

On February 6, 2015, the CNSC announced it had issued an AMP to Isologic Innovative Radiopharmaceuticals Ltd., in the amount of $2,170. The licensee delivered a number of packages that were contaminated above the CNSC regulatory limit. This resulted in a failure to comply with sub-section 16(4) of the CNSC Packaging and Transport of Nuclear Substances Regulations (Failure of consignor or carrier to act in accordance with paragraphs 501 to 547 of the IAEA Regulations for the Safe Transport of Radioactive Material).