USA Medical 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 procedures for acceptance activities, as required by 21 CFR § 820.80(a).

Passage 2

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

Passage 3

Failure to establish procedures for control and distribution of finished devices, as required by 21 CFR § 820.160(a).

Passage 4

Failure to establish procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR § 820.50.

Passage 5

Failure to establish procedures for corrective and preventative action, as required by 21 CFR § 820.100(a).

Passage 6

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

Passage 7

Failure to establish procedures to control environmental conditions as required by 21 CFR § 820.70(c).

Passage 8

Failure to establish and maintain adequate procedures to ensure that mix-ups, damage, deterioration, contamination, or other adverse effects to product do not occur during handling as required by 21 CFR § 820.140.

Passage 9

Failure to establish procedures for quality audits as required by 21 CFR § 820.22.

Passage 10

Failure to establish procedures for management review as required by 21 CFR § 820.20(c).

Passage 11

Failure to establish procedures for training and identifying training needs as required by 21 CFR § 820.25(b).

Passage 12

Failure to establish a policy, and objectives for, and commitment to, quality as required by 21 CFR § 820.20(a).

Passage 13

Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17.