FDA Inspection
UNILAM CO., LTDUNILAM CO., LTD – FDA Inspection, Dec 8, 2022
Record Details
This FDA Inspection record concerns UNILAM CO., LTD, with an inspection on December 8, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- UNILAM CO., LTD
- Inspection Date
- December 8, 2022
- Product Type
- Devices
View Company Profile
ID · a1c37440-2ab3-4604-9691-5bcd04497751
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1192582
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.50(b)Approval, inadequate purchasing data
- 21 CFR 820.184DHR content
- 21 CFR 820.50(b)Supplier notification of changes
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Other FDA inspections of UNILAM CO., LTD
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 30, 2017 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
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