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# North American Diagnostics Illegal Covid Tests
- URL: https://www.fdaweb.com/north-american-diagnostics-illegal-covid-tests/
- Published: 2023-04-19T12:00:00.000Z
- Updated: 2026-09-14T18:26:33.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154250

A 6/14-6/23/22 FDA inspection at the North American Diagnostics medical device operations in Holly Hill, FL, found that the firm manufactures and distributes several unapproved Covid-19 tests. A just-released 12/27/22 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/north-american-diagnostics-llc-643203-12272022?ref=fdaweb.com) says the company acknowledged that it had “improperly distributed into commerce” Covid-19 test kits.

The letter says the kits are misbranded and adulterated and do not comply with current good manufacturing practice requirements of the Quality System Regulation. Specific violations were:

- failing to establish and maintain design control procedures to ensure that specified design requirements of the device are met;
- failing to develop, conduct, control, and monitor production processes to ensure the device conforms to its specifications;
- failing to adequately ensure that the results of a process that cannot be fully verified by subsequent inspection and test shall be validated with a high degree of assurance and approved according to established procedures;
- failing to establish procedures for acceptance activities;
- failing to establish procedures for corrective and preventive action;
- failing to establish procedures for the control and distribution of finished devices;
- failing to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit; and
- failing to establish an organizational structure to ensure that devices are designed and produced according to regulatory requirements.

The letter also says the company has not established procedures for timely and effective identification, communication, and evaluation of reportable events; a standardized review process for determining when an event meets reportability criteria; timely submission of Medical Device Reports to FDA; or for compliance with the applicable documentation and recordkeeping requirements.

The letter says that while North American responded that it had no corrective actions to propose because it has not manufactured test kits at the Holly Hill facility since 7/2021 and does not plan to manufacture rapid antigen test kits in the near future, due to its previously distributed devices it still is required to develop, implement, and maintain Medical Device ⁹ procedures and ensure timely reporting of reportable events involving any device it manufactured.

The firm was told to take prompt action to address any violations and prevent future violations. It was told to respond with a list of specific actions it has taken and a schedule for completing the corrections.