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FDA Warning Letter Explorer
FDA warning letter · Medical Devices

I.T.S. GmbH

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 and maintain procedures for implementing corrective and preventive action, per 21 CFR 820.100(a).

Passage 2

Failure to adequately develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. For example, during the inspection, your firm presented the following documents as your written MDR procedure.

Citations in the original letter

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

  • 21 CFR 803.17(a)(1)
  • 21 CFR 803.3
  • 21 CFR 803.50(a)
  • 21 CFR 803.17(b)
  • 21 CFR 803.18(b)(1)(i)
  • 21 CFR 803.17
  • 21 CFR 803
  • 21 CFR 820.184
  • 21 CFR 820.100(a)