21 CFR 820.140: Handling
Required manufacturers to establish and maintain procedures ensuring product was not mixed up, damaged, deteriorated, contaminated, or otherwise adversely affected during handling.
Part 820, Quality System Regulation · Subpart L, Handling, Storage, Distribution, and Installation
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 820.140, from the 483s we hold.
Procedures for product handling have not been adequately established.Most used
Recent 483s citing 820.140
- Lonza Walkersville, Inc · Walkersville, MarylandProcedures for product handling have not been adequately established… Feb 6, 2017
- Cook Inc · Bloomington, IndianaProcedures for product handling have not been established… Jan 26, 2017
- Trimed Inc · Santa Clarita, CaliforniaProcedures for product handling have not been adequately established… Mar 18, 2016
- St. Jude Medical Puerto Rico LLC · Arecibo, MarylandProcedures for product handling have not been adequately established… Oct 2, 2012
- Advanced Medical Optics, Inc · Santa Ana, CaliforniaAppropriate procedures have not been defined and documented for controlling… Jun 25, 2007
The regulation text
§ 820.140 Handling. As published before it was replaced.
Each manufacturer shall establish and maintain procedures to ensure that mixups, damage, deterioration, contamination, or other adverse effects to product do not occur during handling.
Questions
What does 21 CFR 820.140 require?
Required manufacturers to establish and maintain procedures ensuring product was not mixed up, damaged, deteriorated, contaminated, or otherwise adversely affected during handling.
How do FDA investigators word a 820.140 observation?
The most common opening is: “Procedures for product handling have not been adequately established.”
Which sections are cited alongside 820.140?
In the same 483s, investigators most often also cite 820.198 (Complaint files), 820.70 (Production and process controls), 820.100 (Corrective and preventive action), 820.30 (Design controls).