FDA Inspection
Arklign Laboratories, Inc.Arklign Laboratories, Inc. – FDA Inspection, Oct 28, 2025
Record Details
This FDA Inspection record concerns Arklign Laboratories, Inc., with an inspection on October 28, 2025, issued by the San Francisco District Office, covering medical devices & rad health.
- Company
- Arklign Laboratories, Inc.
- Inspection Date
- October 28, 2025
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 26fb6224-6ab1-47d2-ab49-bc81cc6f1fa8
Inspection Facts
- Inspection number
- 1289036
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
6- 21 CFR 801.20(a)Label to bear a unique device identifier
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
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