FDA Inspection
Unomedical Sdn. Bhd.Unomedical Sdn. Bhd. – FDA Inspection, Dec 6, 2012
Record Details
This FDA Inspection record concerns Unomedical Sdn. Bhd., with an inspection on December 6, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Unomedical Sdn. Bhd.
- Inspection Date
- December 6, 2012
- Product Type
- Devices
View Company Profile
ID · 22e5d32f-23a5-4231-aa12-c2a41f3d2845
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 812771
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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