FDA Inspection
Cargille-Sacher Laboratories Inc.Cargille-Sacher Laboratories Inc. – FDA Inspection, Apr 16, 2009
Record Details
This FDA Inspection record concerns Cargille-Sacher Laboratories Inc., with an inspection on April 16, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 16, 2009
- Product Type
- Devices
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ID · c7394b3b-0551-4c83-aaf3-1355c72132bf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 578223
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling plans
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Other FDA inspections of Cargille-Sacher Laboratories Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 8, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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