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FDA Warning Letter Explorer
FDA warning letter · Medical Devices

Mectronic Medicale S.R.L.

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 establish and maintain a DHF for each type of device, as required by 21 CFR 820.30(j).

Passage 2

Failure to ensure that where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures, as required by 21 CFR 820.75(a).

Passage 3

Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90.

Passage 4

Failure to establish and maintain procedures acceptance activities, as required by 21 CFR 820.80.

Passage 5

Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).

Passage 6

Failure to establish and maintain instructions and procedures for performing and verifying that the servicing meets the specified requirements, as required by 21 CFR 820.200.

Passage 7

Failure to establish procedures for identifying training needs and ensure that all personal are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b).

Passage 8

Failure to maintain device history records as required by 21 CFR 820.184.

Passage 9

Failure to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22.

Citations in the original letter

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

  • 21 CFR 1000
  • 21 CFR 1002.10
  • 21 CFR 1002
  • 21 CFR 1002.13
  • 21 CFR 1010.2
  • 21 CFR 1010
  • 21 CFR 1040.10
  • 21 CFR 1040.10(g)(3)
  • 21 CFR 1040.10(h)(1)(iii)
  • 21 CFR 803.17
  • 21 CFR 803
  • 21 CFR 807.81(a)(3)(ii)
  • 21 CFR 807.81(3)(a)(i)
  • 21 CFR 807.81(b)
  • 21 CFR 820.30(j)
  • 21 CFR 820.30
  • 21 CFR 820.75(a)
  • 21 CFR 820.90
  • 21 CFR 820.80
  • 21 CFR 820.198(a)
  • 21 CFR 820.200
  • 21 CFR 820.25(b)
  • 21 CFR 820.184
  • 21 CFR 820.22
  • 21 CFR 890.5500
  • 21 CFR 890.9(a)
  • 21 CFR 890.9(b)