Exer Labs, Inc.

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 adequately establish procedures for design controls as required by 21 CFR 820.30(a).

Passage 2

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

Passage 3

Failure to adequately establish procedures for corrective and preventive actions as required by 21 CFR 820.100(a).

Passage 4

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

Passage 6

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

Passage 7

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