21 CFR 820.60: Identification
Required manufacturers to establish and maintain procedures identifying product at every stage of receipt, production, distribution, and installation so that mixups are prevented.
Part 820, Quality System Regulation · Subpart F, Identification and Traceability
Most device 483s cite the Quality System Regulation in force before February 2, 2026, when the QMSR replaced it. Those sections are marked Former.
How FDA words it
The opening lines investigators use most when they cite 820.60, from the 483s we hold.
Procedures for identifying product during all stages of receipt, production, distribution, and installation have not been adequately established.Most used
Recent 483s citing 820.60
- MAVIDON MEDICAL PRODUCTS · Flat Rock, North CarolinaProcedures for identifying product during all stages of receipt, production,… Aug 5, 2025
- The Richline Group, Inc. · Tamarac, FloridaProcedures for identifying product during all stages of receipt, production,… Apr 16, 2025
- Medicraft, Inc · Elmwood Park, New JerseyProcedures for identifying product dining all stages of receipt, production,… Nov 27, 2024
- GPS DENTAL LAB, INC · Orlando, FloridaProcedures for identifying product during all stages of receipt, production,… Nov 5, 2024
- Reach Medical Inc · Collierville, TennesseeProcedures for identifying product during all stages of receipt, production,… Dec 30, 2022
The regulation text
§ 820.60 Identification. As published before it was replaced.
Each manufacturer shall establish and maintain procedures for identifying product during all stages of receipt, production, distribution, and installation to prevent mixups.
Questions
What does 21 CFR 820.60 require?
Required manufacturers to establish and maintain procedures identifying product at every stage of receipt, production, distribution, and installation so that mixups are prevented.
How do FDA investigators word a 820.60 observation?
The most common opening is: “Procedures for identifying product during all stages of receipt, production, distribution, and installation have not been adequately established.”
Which sections are cited alongside 820.60?
In the same 483s, investigators most often also cite 820.198 (Complaint files), 820.100 (Corrective and preventive action), 820.70 (Production and process controls), 820.72 (Inspection, measuring, and test equipment).