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FDA Warning Letter Explorer
FDA warning letter · Medical Devices

RightEye, LLC

Issued · Posted by FDA

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 to control the design of the device to ensure that specified design requirements are met, as required by 21 CFR 820.30. Specifically, your firm has no written design control procedures.

Passage 2

Failure to establish and maintain a design history file (DHF) that contains or references the records necessary to demonstrate that the design was developed in accordance with the approved design plan and design control requirements, as required by 21 CFR 820.30(j).

Passage 3

Failure to establish and maintain procedures to control product that does not conform to specified required, as required by 21 CFR 820.90. Specifically, you have not established procedures concerning the control of nonconforming product.

Passage 4

Failure to establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants, as required by 21 CFR 820.50(a).

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 803
  • 21 CFR 807.81(a)(3)(ii)
  • 21 CFR 820.30
  • 21 CFR 820.30(j)
  • 21 CFR 820.198(a)
  • 21 CFR 820.90
  • 21 CFR 820.50(a)
  • 21 CFR 830
  • 21 CFR 830.300(a)
  • 21 CFR 830.3
  • 21 CFR 882.1460