North American Diagnostics, LLC

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Failure to establish and maintain design control procedures in order to ensure that specified design requirements of the device are met, as required by 21 CFR 820.30(a).** Specifically, your firm did not establish design control procedures prior to the manufacture and distribution of your COVID-19 test.

Passage 2

Failure to develop, conduct, control, and monitor production processes to ensure the device conforms to its specifications, as required by 21 CDR 820.70.** Specifically, your firm has not established production processes controls for your COVID-19 test, for any production and process changes, environmental control requirements, personnel requirements, contamination control requirements, manufacturing material requirements, or automated processes requirements.

Passage 3

Failure to adequately ensure that the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance and approved according to established procedure, as required by 21 CFR 820.75(a).** Specifically, your firm has not conducted process validations for those processes that your firm cannot fully verify in the manufacture of your COVID-19 Test.

Passage 4

Failure to establish procedures for acceptance activities, as required by 21 CFR 820.80.** Specifically, your firm has not established 1) receiving acceptance activities for any components used to manufacture your COVID-19 Test, 2) in-process acceptance activities for any process critical to the functionality and/or intended use of the device, 3) final acceptance activities.

Passage 5

Failure to establish procedures for corrective and preventive action, as required by 21 CFR 820.100(a).** Specifically, your firm has not established procedures, instructions, or processes to identify, investigate, and correct problems that are observed and to prevent recurrence of issues.

Passage 6

Failure to establish procedures for control and distribution of finished devices, as required by 21 CFR 820.160(a).** Specifically, your firm does not have procedures for control and distribution of your COVID-19 Test.

Passage 7

Failure to establish an organizational structure to ensure that devices are designed and produced in accordance 21 CFR part 820.20(b).** Specifically, you have not established an organizational structure that defines the responsibilities and authority, resources, management representative, management review, quality planning and quality system procedures in accordance with good manufacturing practices set forth in the Quality System Regulation.