Noah Medical Corporation

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 procedures for corrective and preventive action, as required by 21 CFR 820.100(a).

Passage 2

Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).

Passage 3

Failure to establish and maintain procedures for design control, as required by 21 CFR 820.30.

Passage 4

Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a).

Passage 5

Failure to establish and maintain procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications, as required by 21 CFR 820.90(b)(2). Rework and reevaluation activities, including a determination of any adverse effect from the rework upon the product, shall be documented in the device history record (DHR), as required by 21 CFR 820.90(b)(2).

Passage 6

Failure to submit a report to FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that it markets may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1).