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FDA Warning Letter Explorer
FDA warning letter · Medical Devices

Hong Qiangxing Shenzhen Electronics Limited

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 devices to ensure that specified design requirements are met, as required by 21 CFR 820.30(a). Specifically:

Passage 2

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

Passage 3

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

Passage 4

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

Passage 5

Failure to adequately establish procedures for identifying product during all stages of receipt, production, distribution, and installation, as required by 21 CFR 820.60.

Citations in the original letter

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

  • 21 CFR 820.30(g)
  • 21 CFR 820.30(a)
  • 21 CFR 820.30(i)
  • 21 CFR 820.30(f)
  • 21 CFR 820.30(j)
  • 21 CFR 820.90(a)
  • 21 CFR 820.100(a)
  • 21 CFR 820.198(a)
  • 21 CFR 820.60
  • 21 CFR 820