FDA Inspection
Productos Urologos de Mexico, S.A. de C.V.Productos Urologos de Mexico, S.A. de C.V. – FDA Inspection, Jan 26, 2012
Record Details
This FDA Inspection record concerns Productos Urologos de Mexico, S.A. de C.V., with an inspection on January 26, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 26, 2012
- Product Type
- Devices
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ID · e58c6565-dfa0-4e86-9a2c-0058e262ea32
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 767991
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Productos Urologos de Mexico, S.A. de C.V.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 24, 2019 | Not classified | Office of Inspections and Investigations | |
| December 2, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Productos Urologos de Mexico, S.A. de C.V.
- FDA Inspection 1134839 - 2019-07-24
- FDA Inspection 1003137 - 2016-12-02
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