FDA Inspection
Zulco International IncZulco International Inc – FDA Inspection, Aug 9, 2010
Record Details
This FDA Inspection record concerns Zulco International Inc, with an inspection on August 9, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Zulco International Inc
- Inspection Date
- August 9, 2010
- Product Type
- Devices
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ID · ddd5b77e-80fb-49f9-a37e-6772d051e0d5
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 675593
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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