FDA Inspection
Linet Spol. S.r.o.Linet Spol. S.r.o. – FDA Inspection, Nov 1, 2012
Record Details
This FDA Inspection record concerns Linet Spol. S.r.o., with an inspection on November 1, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Linet Spol. S.r.o.
- Inspection Date
- November 1, 2012
- Product Type
- Devices
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ID · c1f8072c-9cfb-4ef4-a925-f2719d867223
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 805089
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.180Availability
- 21 CFR 803.17Lack of Written MDR Procedures
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