FDA Inspection
MedLine Industries, LP (NAMIC Division)MedLine Industries, LP (NAMIC Division) – FDA Inspection, Dec 12, 2025
Record Details
This FDA Inspection record concerns MedLine Industries, LP (NAMIC Division), with an inspection on December 12, 2025, covering devices.
- Inspection Date
- December 12, 2025
- Product Type
- Devices
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ID · e6fb87ab-c6d2-4e44-a0e4-e14d01325070
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1294910
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 803.50(b)(1)Reporting Information Reasonably Known
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.75(a)Lack of or inadequate process validation
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