FDA Inspection
Sypris Electronics LlcSypris Electronics Llc – FDA Inspection, Jun 14, 2019
Record Details
This FDA Inspection record concerns Sypris Electronics Llc, with an inspection on June 14, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ed04007b-41cd-4c76-9ca9-59a33560796b
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1093280
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.184DHR content
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Sypris Electronics Llc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 16, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Sypris Electronics Llc
- FDA Inspection 1215825 - 2023-08-16
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