FDA Inspection
World Merchant Inc. dba OrthoextentWorld Merchant Inc. dba Orthoextent – FDA Inspection, Apr 16, 2025
Record Details
This FDA Inspection record concerns World Merchant Inc. dba Orthoextent, with an inspection on April 16, 2025, issued by the Baltimore District Office, covering medical devices & rad health.
- Inspection Date
- April 16, 2025
- Product Type
- Medical Devices & Rad Health
- Person
View Company Profile
ID · 77318729-4cfd-49ec-9ebb-c3c0e31b88cd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1267501
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
9- 21 CFR 820.160(a)Lack of or inadequate procedures for distribution
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(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 830.300(a)Devices subject to device identification GUDID data submission requirements.
- 21 CFR 801.20(a)Label to bear a unique device identifier
- 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 |
|---|---|---|---|
| January 9, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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