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FDA Warning Letter Explorer
FDA warning letter · Medical Devices

Getsch+Hiller Medizintechnik GmbH

Issued · Posted by FDA

FDA published a close-out letter on Sep 29, 2023. The passages below are from the original warning letter.

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 design history file (DHF) for each of the products that GH manufactures, as required by 21 CFR 820.30(j).

Passage 2

Failure to establish and maintain procedures for acceptance of incoming product as required by 21 CFR 820.80(b).

Citations in the original letter

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

  • 21 CFR 807.81(a)(3)
  • 21 CFR 807.81(b)
  • 21 CFR 820.30(j)
  • 21 CFR 820.80(b)