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FDA Warning Letter Explorer
FDA warning letter · Medical Devices

Jiangsu Shenli Medical Production Co., Ltd.

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 in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a)(1).

Passage 2

Failure to establish and maintain device master records, as required by 21 CFR 820.181.

Citations in the original letter

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

  • 21 CFR 820.30(a)(1)
  • 21 CFR 820.181