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FDA Warning Letter Explorer
FDA warning letter · Medical Devices

LEVO AG

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 a quality system that is appropriate for the specific medical devices designed and manufactured as required by 21 CFR 820.5.

Passage 2

Failure to adequately develop, maintain, and implement written Medical Device Reporting procedures, as required by 21 CFR 803.17.

Passage 3

Failure to ensure that the labeler of a device provide the information required by the subpart for each version or model required to bear a unique device identifier, as required by 21 CFR 830.300.

Citations in the original letter

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

  • 21 CFR 803.17
  • 21 CFR 803
  • 21 CFR 806
  • 21 CFR 820
  • 21 CFR 820.5
  • 21 CFR 820.20
  • 21 CFR 820.22
  • 21 CFR 820.25
  • 21 CFR 820.30
  • 21 CFR 820.40
  • 21 CFR 820.50
  • 21 CFR 820.60
  • 21 CFR 820.65
  • 21 CFR 820.70
  • 21 CFR 820.72
  • 21 CFR 820.75
  • 21 CFR 820.80
  • 21 CFR 820.86
  • 21 CFR 820.90
  • 21 CFR 820.100
  • 21 CFR 820.120
  • 21 CFR 820.130
  • 21 CFR 820.140
  • 21 CFR 820.150
  • 21 CFR 820.160
  • 21 CFR 820.170
  • 21 CFR 820.180
  • 21 CFR 820.181
  • 21 CFR 820.184
  • 21 CFR 820.186
  • 21 CFR 820.198
  • 21 CFR 820.200
  • 21 CFR 820.250
  • 21 CFR 830.300
  • 21 CFR 830
  • 21 CFR 890.3900