FDA Inspection
World Merchant Inc. dba OrthoextentWorld Merchant Inc. dba Orthoextent – FDA Inspection, Jan 9, 2018
Record Details
This FDA Inspection record concerns World Merchant Inc. dba Orthoextent, with an inspection on January 9, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d2d9b12f-75a9-44e9-8819-a9a6e9f08ec7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1037510
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.160(a)Lack of or inadequate procedures for distribution
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.140Lack of or inadequate procedures for handling
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of World Merchant Inc. dba Orthoextent
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 16, 2025 | VAI | Baltimore District Office | Compliance: Medical Devices |
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