Facility Registration, Import Problems Keep CDRH Compliance Office Busy

Full article reprinted from "The Gray Sheet" - October 19, 2009

CDRH Compliance Director Tim Ulatowski gave an update last week on activities at his office, including import safety efforts and a notable warning letter push. Read more...

Facility Registration, Import Problems Keep CDRH Compliance Office Busy

Full article reprinted from "The Gray Sheet" - October 19, 2009

CDRH Compliance Director Tim Ulatowski gave an update last week on activities at his office, including import safety efforts and a notable warning letter push.

Speaking at the Food and Drug Law Institute Enforcement and Litigation Conference in Washington, D.C., Oct. 13, Ulatowski said the environment at FDA is shifting to faster and more aggressive action to address regulatory problems.

Registration & Listing Issues

CDRH is currently chasing down firms that have yet to register and list their facilities in accordance with recent FDA regulations.

Since October 2007, domestic device companies and foreign firms that manufacture or process a device sold in the U.S. have been required to register and pay an annual facility registration fee for all their establishments, unless waived by FDA.

Ulatowski said the device center sent out 10,052 untitled letters to industry in fiscal 2008, many of them to firms that had not registered their facilities.

The letters helped, but gaining full compliance and collecting the registration fees remains a challenge, Ulatowski said.

FDA issued guidance Oct. 8 explaining the requirements and how to use FDA's electronic R&L system (The Gray Sheet' Oct. 12, 2009).

Defective Imported Titanium In Devices

The compliance office is also busy tracking a defective batch of titanium manufactured in a single facility in China but used by many firms, predominantly orthopedic device makers.

Several batches, or melts, of titanium from the Chinese plant did not meet manufacturing specifications, Ulatowski explained. The defective raw material then made its way from distributors to at least 130 manufacturers who used the titanium.

FDA has contacted the firms and suggested appropriate actions to take, Ulatowski said, which has "already resulted in some precautionary recalls."

The agency is investigating other titanium sources distributed from China and elsewhere, he added.

The titanium problem is "just one example" of new import safety issues FDA is facing. Ulatowski said the agency is considering greater use of important detentions to deal with such problems.

In the meantime, the device center is piloting FDA's new PREDICT import screening program in certain jurisdictions, including Los Angeles, in preparation for a full rollout in the future. The Predictive Risk-Based Evaluation of Dynamic Import Compliance Targeting system is designed to more quickly identify non-compliant products by scoring imports based on risk (The Gray Sheet' Aug. 17, 2009).

Warning Letter Push

Finally, Ulatowski said a string of warning letters will be issued in the next week or so, targeted at "chronic issues" and public health concerns. "This will be a notable action," he said.

The long-time FDA staffer added that he hopes to address areas of "chronic problems," such as cardiac devices and infusion pumps, "in the time I have left" at the agency.

- Jessica Bylander

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