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FDA Warning Letter Explorer
FDA warning letter · Medical Devices

Magnolia Medical Technologies, Inc.

Issued · Posted by FDA

FDA published a close-out letter on May 18, 2022. 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 adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example,

Passage 2

Failure to establish and maintain adequate procedures for verifying the device design to confirm that the design output meets the design input requirements, as required by 21 CFR 820.30(f).

Passage 3

Failure to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications, as required by 21 CFR 820.70(a).

Citations in the original letter

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

  • 21 CFR 820.100(a)
  • 21 CFR 820.30(f)
  • 21 CFR 820.70(a)