FDA Inspection
Soleetech CorporationSoleetech Corporation – FDA Inspection, May 15, 2013
Record Details
This FDA Inspection record concerns Soleetech Corporation, with an inspection on May 15, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Soleetech Corporation
- Inspection Date
- May 15, 2013
- Product Type
- Devices
View Company Profile
ID · 8b745601-113c-467e-bc0e-550dd56116d6
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 836839
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.198(a)General
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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