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FDA Warning Letter Explorer
FDA warning letter · Medical Devices

Optikem International, Inc.

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 validate processes used to produce devices labeled as “sterile” according to 21 CFR 820.75.

Passage 2

Failure to ensure equipment used to manufacture devices labeled as “sterile” is routinely calibrated according to 21 CFR 820.70.

Passage 3

Failure to establish design control procedures and implement requirements to devices labeled as “sterile” according to 21 CFR 820.30.

Passage 4

Failure to establish CAPA procedures according to 21 CFR 820.100.

Citations in the original letter

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

  • 21 CFR 801.20(a)
  • 21 CFR 801.3
  • 21 CFR 801.40(a)(1)
  • 21 CFR 801.40(a)(2)
  • 21 CFR 801
  • 21 CFR 807.81(a)(3)(i)
  • 21 CFR 807.81(b)
  • 21 CFR 820.75
  • 21 CFR 820.70
  • 21 CFR 820.30
  • 21 CFR 820.100
  • 21 CFR 830
  • 21 CFR 830.300(a)
  • 21 CFR 830.3