21 CFR 820.150: Storage
Required manufacturers to maintain procedures controlling storage areas and stock rooms to prevent mixups, damage, and deterioration, ensure stock rotation and no use of obsolete or rejected product, and authorize receipt and dispatch.
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 820.150, from the 483s we hold.
Procedures for the control of storage areas and stock rooms have not been adequately established.Most used
Recent 483s citing 820.150
- Ming Fai Industrial (Shenzhen) Co., Ltd. · Shenzhen, Guangdong, ChinaProcedures for the control of storage areas and stock rooms have not been… Mar 10, 2023
- TERRIFIC CARE LLC · Passaic, New JerseyProcedures for the control of storage areas and stock rooms have not been… Feb 5, 2019
- Spineology, Inc · Saint Paul, MinnesotaProcedures for the contr ol of storage areas and stock rooms have not been… Mar 31, 2017
- Medtronic Inc · Northridge, CaliforniaProcedures for the control of storage areas and stock rooms have not been… Mar 24, 2017
- Simpro, LLC · Irving, TexasFailure to establish and maintain procedures for the control of storage areas and… Jul 7, 2016
The regulation text
§ 820.150 Storage. As published before it was replaced.
(a)Each manufacturer shall establish and maintain procedures for the control of storage areas and stock rooms for product to prevent mixups, damage, deterioration, contamination, or other adverse effects pending use or distribution and to ensure that no obsolete, rejected, or deteriorated product is used or distributed. When the quality of product deteriorates over time, it shall be stored in a manner to facilitate proper stock rotation, and its condition shall be assessed as appropriate.
(b)Each manufacturer shall establish and maintain procedures that describe the methods for authorizing receipt from and dispatch to storage areas and stock rooms.
Questions
What does 21 CFR 820.150 require?
Required manufacturers to maintain procedures controlling storage areas and stock rooms to prevent mixups, damage, and deterioration, ensure stock rotation and no use of obsolete or rejected product, and authorize receipt and dispatch.
How do FDA investigators word a 820.150 observation?
The most common opening is: “Procedures for the control of storage areas and stock rooms have not been adequately established.”
Which sections are cited alongside 820.150?
In the same 483s, investigators most often also cite 820.198 (Complaint files), 820.100 (Corrective and preventive action), 820.80 (Receiving, in-process, and finished device acceptance), 820.90 (Nonconforming product).