FDA Inspection
Sterex Electrolysis Int LtdSterex Electrolysis Int Ltd – FDA Inspection, Feb 14, 2013
Record Details
This FDA Inspection record concerns Sterex Electrolysis Int Ltd, with an inspection on February 14, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sterex Electrolysis Int Ltd
- Inspection Date
- February 14, 2013
- Product Type
- Devices
View Company Profile
ID · fbcaef88-11b9-4790-9a1f-b6612e64aa2c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 821451
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.80(b)Incoming acceptance records, documentation
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.86Acceptance status
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Other FDA inspections of Sterex Electrolysis Int Ltd
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 6, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Sterex Electrolysis Int Ltd
- FDA Inspection 904085 - 2014-11-06
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