FDA Inspection
REMINGTON MEDICAL, S.A.REMINGTON MEDICAL, S.A. – FDA Inspection, Aug 14, 2014
Record Details
This FDA Inspection record concerns REMINGTON MEDICAL, S.A., with an inspection on August 14, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- REMINGTON MEDICAL, S.A.
- Inspection Date
- August 14, 2014
- Product Type
- Devices
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ID · 5b6e3f39-814e-4387-bbe9-e224b4d3cc47
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 894270
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
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Other FDA inspections of REMINGTON MEDICAL, S.A.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 30, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 25, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for REMINGTON MEDICAL, S.A.
- FDA Inspection 1068874 - 2018-08-30
- FDA Inspection 936435 - 2015-06-25
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