Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure to adequately establish and maintain procedures for acceptance activities, as required by 21 CFR 820.80(a). For example:
Passage 2Failure to establish and maintain a Design History Files (DHF) for each type of device, as required under 21 CFR 820.30(j). Specifically, your firm failed to establish Design History Files for the LK128 Series and the LU700 Series ultrasound imaging systems.
Passage 3Failure to adequately implement production and process control procedures to ensure conformance to specifications have been met, as required under 21 CFR 820.70(a). Specifically, your firm did not include all necessary assembly steps on manufacturing instructions for the LU700 Series Diagnostic Ultrasound Systems. Your firm’s LU700 Assembly Operation Specifications, Document #LK_QI-AMY-001, Revision G, failed to include production steps to **(b)(4)** and other device components.
Passage 4Failure to adequately establish procedures for the control of labeling operations to ensure that the label and labeling used for each production unit, lot, or batch is documented in the Device History Record (DHR), as required under 21 CFR 820.120(d). Specifically, DHRs pertaining to your firm’s Leltek Ultrasonic Imaging Systems failed to include or refer to the location of the label and labeling applied to each production unit, lot, or batch.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 803
- 21 CFR 803.17
- 21 CFR 803.17(a)(1)
- 21 CFR 803.3
- 21 CFR 803.20(c)(1)
- 21 CFR 803.50(a)
- 21 CFR 803.17(a)(2)
- 21 CFR 803.17(a)(3)
- 21 CFR 803.12(a)
- 21 CFR 803.10
- 21 CFR 803.52
- 21 CFR 803.17(b)
- 21 CFR 803.18(b)(1)
- 21 CFR 803.18(b)(1)(i)
- 21 CFR 820.198(a)
- 21 CFR 820.50(a)
- 21 CFR 820.80(a)
- 21 CFR 820.30(j)
- 21 CFR 820.30
- 21 CFR 820.70(a)
- 21 CFR 820.120(d)