FDA Inspection
Saltillo CorporationSaltillo Corporation – FDA Inspection, Sep 10, 2013
Record Details
This FDA Inspection record concerns Saltillo Corporation, with an inspection on September 10, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Saltillo Corporation
- Inspection Date
- September 10, 2013
- Product Type
- Devices
View Company Profile
ID · beda015e-a47d-47c6-be96-5ab34f51d8b1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 847810
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
10- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Saltillo Corporation
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 6, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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