FDA Inspection
UNILAM CO., LTDUNILAM CO., LTD – FDA Inspection, Jun 30, 2017
Record Details
This FDA Inspection record concerns UNILAM CO., LTD, with an inspection on June 30, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · e9ccd9e2-f111-4289-875f-30801e36d241
Inspection Facts
- Inspection number
- 1019783
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 1010.3(a)(2)ID label lacks place, month & year of manufacture
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
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Other FDA inspections of UNILAM CO., LTD
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 8, 2022 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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