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# FDA Troubled by Chinese Firms Using Fictitious U.S. Agent
- URL: https://www.fdaweb.com/fda-troubled-by-chinese-firms-using-fictitious-u-s-agent/
- Published: 2020-06-22T12:00:00.000Z
- Updated: 2026-09-14T16:19:00.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147063

*\[Report by David McFarland)* FDA is learning fast that relaxing its standards during the Covid-19 pandemic causes many problems that it now struggles to contain and correct. The first troubles began with Covid-19 testing after FDA allowed testing laboratories and various manufacturers market access with minimal data and no validation. This was corrected and test makers now must demonstrate with data that their devices perform as expected.

Now, the agency is contending with over 1,300 Chinese firms that used an FDA-recognized but fictitious U.S. agent when registering their protective masks and other gear in the agency’s database. The U.S. agent, CCTC Service (Wilmington, DE), was disclosed in a recent [Justice Department complaint](https://www.justice.gov/usao-nj/press-release/file/1283346/download?ref=fdaweb.com) against King Year Printing And Packaging Co. over misbranded face respirators. CCTC’s address was a residential home whose residents had no idea about the scheme. Attempts to contact CCTC by phone and email also proved futile, according to the complaint. Additionally, the complaint included statements from FDA Office of Criminal Investigations special agent **Donald Pearlman**, who said foreign manufacturers of counterfeit goods use fictitious corporations as U.S. agents to circumvent regulatory oversight of their products. The 1,300 firms using the same agent was [reported](https://www.wsj.com/articles/over-1-300-chinese-medical-suppliers-to-u-s-including-mask-providersuse-bogus-registration-data-11591991270?ref=fdaweb.com) initially by the *Wall Street Journal*.

While an FDA spokesperson told ***FDA Webview*** that it is agency policy not to confirm or deny the existence of ongoing investigations, recent enforcement actions and policy changes suggest the agency is addressing the questionable device registration process, at least with face mask/respirators. “In response to continued concerns with respirator availability during the Covid-19 emergency, supply chain disruptions and hearing from health care facilities who sought access to these products to meet their needs, we issued a separate EUA for non-(National Institute for Occupational Safety and Health)-approved respirators manufactured in China on 4/3, recognizing the importance of putting in place additional safeguards due to concerns we had about fraudulent products listed as KN95 respirators,” the FDA spokesperson said. “We have subsequently tightened those safeguards and reissued the EUA on 5/7, and then we tightened it even further and revised and reissued the EUA again on 6/6\. As part of tightening our controls and introducing safeguards against fraudulent product, FDA revised the conditions of authorization in the 5/7 reissuance to only accept EUA requests submitted directly by the manufacturer in China and not from U.S. agents or importers.”

FDA’s regulations require any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the U.S. to identify a U.S. agent for that establishment. FDA says it will contact overseas companies through these contacts to facilitate coordinated inspections, and communicate or respond to other urgent needs. **Vernessa Pollard**, a former FDA law enforcement lawyer and a partner at McDermott Will & Emery law firm, is quoted in a [news report ](https://gnews.org/238822/?ref=fdaweb.com)at *gnews.org* as saying that “if a product has a problem for some reason or the product needs to be recalled, the main contact between FDA and the manufacturer is through a registered agent. If a foreign manufacturer doesn’t have proper contact information, that would be ‘a huge danger.’”

“Most establishments that are required to register are also required to list the devices and the activities performed on those devices at that establishment,” the FDA spokesperson said. “It is important to note that registration and listing does not denote approval or clearance of a firm or their devices... FDA does not issue registration certificates to medical device establishments. FDA does not certify registration and listing information for firms that have registered and listed. Registration and listing does not denote approval or clearance of a firm or their devices. Product clearance or approval status may be verified by searching either the [Premarket Approvals (PMA)](http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?ref=fdaweb.com) or [Premarket Notifications (510(k)s)](http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ref=fdaweb.com) databases and entering the product name in the search criteria. Additionally, to verify if specific products have been authorized for emergency use during the Covid-19 emergency it is best to reference the [Emergency Use Authorizations](https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations?ref=fdaweb.com#coronavirus2019) page.”

Retired attorney and former medical device compliance director **Larry** **Pilot** told ***FDA Webview*** 6/22 that the disconnect between the device registration process and any related device clearance/approval is troubling. He suggested that FDA should identify all 1,300 false registrants and ensure that product recalls are initiated. Pilot also hinted that Congress should be interested in knowing “what went wrong.”