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FDA Warning Letter Explorer
FDA warning letter · Medical Devices

Caltag Medsystems Ltd

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 adequate procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device's design development, as required by 21 CFR 820.30(e). For example:

Passage 2

Failure to establish and maintain adequate procedures to ensure that the device design is correctly translated into production specification, as required by 21 CFR 820.30(h). For example:

Passage 3

Failure to establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained. These activities shall be documented, as required by 21 CFR 820.72(a). For example:

Citations in the original letter

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

  • 21 CFR 820.100
  • 21 CFR 820.30(e)
  • 21 CFR 820.30(h)
  • 21 CFR 820.75(a)
  • 21 CFR 820.72(a)
  • 21 CFR 820.120(b)