FDA Inspection
Sanmina Ireland Unlimited CompanySanmina Ireland Unlimited Company – FDA Inspection, May 28, 2026
Record Details
This FDA Inspection record concerns Sanmina Ireland Unlimited Company, with an inspection on May 28, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- May 28, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · ffc4ff2a-2f8e-4fd4-a672-09f58cc4f219
Inspection Facts
- Inspection number
- 1319324
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
- ISO 13485:2016 Clause 7.4.3Purchased product verification activities are inadequate
- ISO 13485:2016 Clause 8.4Procedures for data analysis do not include determination of appropriate methods
- ISO 13485:2016 Clause 8.4Records of data analysis results not maintained
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
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Other FDA inspections of Sanmina Ireland Unlimited Company
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 14, 2023 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 25, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Sanmina Ireland Unlimited Company
- FDA Inspection 1217651 - 2023-09-14
- FDA Inspection 900361 - 2014-09-25
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