FDA Inspection
Crystal Care International IncCrystal Care International Inc – FDA Inspection, Dec 10, 2008
Record Details
This FDA Inspection record concerns Crystal Care International Inc, with an inspection on December 10, 2008, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 10, 2008
- Product Type
- Devices
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ID · cb75bafd-e9b8-471c-868f-2c3d2829f3a0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 551869
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
11- 21 CFR 820.198(a)General
- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.200(b)Analyzing service report
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.181(c)DMR QA procedures and specifications
- 21 CFR 820.100(b)Procedures
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