FDA Inspection
Medsorb Dominicana, S.A.Medsorb Dominicana, S.A. – FDA Inspection, Jan 20, 2016
Record Details
This FDA Inspection record concerns Medsorb Dominicana, S.A., with an inspection on January 20, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medsorb Dominicana, S.A.
- Inspection Date
- January 20, 2016
- Product Type
- Devices
View Company Profile
ID · 19fbd344-81ec-41f0-84ee-5a32e8bd5f4f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 954938
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.70(g)(2)Periodic equipment inspections
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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