FDA Inspection
Linatech, LlcLinatech, Llc – FDA Inspection, Nov 8, 2019
Record Details
This FDA Inspection record concerns Linatech, Llc, with an inspection on November 8, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Linatech, Llc
- Inspection Date
- November 8, 2019
- Product Type
- Devices
View Company Profile
ID · bf794fae-91c3-4827-9f07-16c2ac60c871
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1109221
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
9- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.20(b)(3)Management representative
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.198(b)Rationale documented for no investigation
- 21 CFR 820.20(a)Quality policy and objectives
- 21 CFR 820.20(c)Management review dates
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Other FDA inspections of Linatech, Llc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 29, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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