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FDA Warning Letter Explorer
FDA warning letter · Medical Devices

SeniorLife Technologies, Inc.

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

Passage 2

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 3

Failure to establish procedures for quality audits, as required by 21 CFR § 820.22.

Passage 4

Failure to establish procedures for training and identifying training needs, as required by 21 CFR § 820.25(b).

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 807.81(a)(1)
  • 21 CFR 807.81(b)
  • 21 CFR 820.100(a)
  • 21 CFR 820.198(a)
  • 21 CFR 820.22
  • 21 CFR 820.25(b)
  • 21 CFR 890.5360