FDA Inspection
AOMI PRECISION CO LTDAOMI PRECISION CO LTD – FDA Inspection, Jul 24, 2025
Record Details
This FDA Inspection record concerns AOMI PRECISION CO LTD, with an inspection on July 24, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 28b2c053-963a-4cf9-beb0-d884a40fbfec
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1278397
- FDA center
- Medical Devices & Rad Health
- Project area
- Product Evaluation: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
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