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FDA Warning Letter Explorer
FDA warning letter · Medical Devices

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

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 to ensure that all purchased or otherwise received products and services conform to specified requirements, as required by 21 CFR 820.50. Your firm failed to adequately implement supplier management procedures to ensure that products purchased from your critical supplier and manufacturer of Safe-T-Fill Capillary Collection Tubes, **(b)(4)**, conform to specified requirements.

Passage 2

Failure to adequately develop, maintain, and implement written MDR procedures as

Passage 3

Failure to submit a written report to FDA of any correction or removal of a device initiated to remedy a violation of the Act caused by the device which may present a risk to health, as required by 21 CFR 806.10(a). For example:

Citations in the original letter

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

  • 21 CFR 801.119
  • 21 CFR 801
  • 21 CFR 803.17(a)(3)
  • 21 CFR 803
  • 21 CFR 806.10(a)
  • 21 CFR 806.2(d)
  • 21 CFR 806.10(a)(1)(b)
  • 21 CFR 806
  • 21 CFR 807.81(a)(3)(i)
  • 21 CFR 807.81(b)
  • 21 CFR 809.10
  • 21 CFR 809.10(b)(2)
  • 21 CFR 809.10(a)(8)
  • 21 CFR 820.50
  • 21 CFR 820.30