FDA Inspection
Spes Medica srlSpes Medica srl – FDA Inspection, Oct 4, 2012
Record Details
This FDA Inspection record concerns Spes Medica srl, with an inspection on October 4, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Spes Medica srl
- Inspection Date
- October 4, 2012
- Product Type
- Devices
View Company Profile
ID · c37417a0-b045-4a0b-9912-91f1685f2f50
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 803541
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
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