FDA Inspection
COPIOUS INTL., INC.COPIOUS INTL., INC. – FDA Inspection, Feb 8, 2018
Record Details
This FDA Inspection record concerns COPIOUS INTL., INC., with an inspection on February 8, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · b4242711-770f-45e8-84d1-3b14f3862df4
Inspection Facts
- Inspection number
- 1041574
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
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Other FDA inspections of COPIOUS INTL., INC.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 6, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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