21 CFR 820.120: Device labeling
Required manufacturers to control labeling by keeping labels legible and attached, having a designated person inspect and document release before use, preventing mixups in storage and operations, recording labels in the DHR, and carrying control numbers through distribution.
Part 820, Quality System Regulation · Subpart K, Labeling and Packaging Control
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 820.120, from the 483s we hold.
Procedures to control labeling activities have not been established.Most used
Procedures to control labeling activities have not been adequately established.
Labeling was not sufficiently examined by a designated individual for accuracy including unique device identifier (UDI) or universal product code (UPC).820.120(b)
Cited over time
483s citing 820.120, by yearMost citations in 2022. Bars are relative to the busiest year. *2026 to date.
Years shown: 2017 to 2026. The busiest year was 2022.
Recent 483s citing 820.120
- RAC Medical Solutions · Bruceton, TennesseeProcedures to control labeling activities have not been established… Aug 7, 2025
- Auxilium Medical Inc * · Charleston, South CarolinaThe DHR does not include records of examination and release of device labeling,… Mar 26, 2025
- Simpex Medical Inc · Fort Mill, South CarolinaThe DHR does not include records of examination and release of device labeling,… Jun 28, 2024
- Form 483 · FEI 3014833750 · Durham, North CarolinaLabeling was not sufficiently examined by a designated individual for accuracy… Jun 14, 2024
- Robbins Instruments, LLC · Houston, TexasProcedures to control labeling activities have not been established… May 31, 2024
The regulation text
§ 820.120 Device labeling. As published before it was replaced.
Each manufacturer shall establish and maintain procedures to control labeling activities.
(a)Label integrity. Labels shall be printed and applied so as to remain legible and affixed during the customary conditions of processing, storage, handling, distribution, and where appropriate use.
(b)Labeling inspection. Labeling shall not be released for storage or use until a designated individual(s) has examined the labeling for accuracy including, where applicable, the correct unique device identifier (UDI) or universal product code (UPC), expiration date, control number, storage instructions, handling instructions, and any additional processing instructions. The release, including the date and signature of the individual(s) performing the examination, shall be documented in the DHR.
(c)Labeling storage. Each manufacturer shall store labeling in a manner that provides proper identification and is designed to prevent mixups.
(d)Labeling operations. Each manufacturer shall control labeling and packaging operations to prevent labeling mixups. The label and labeling used for each production unit, lot, or batch shall be documented in the DHR.
(e)Control number. Where a control number is required by § 820.65, that control number shall be on or shall accompany the device through distribution.
[61 FR 52654, Oct. 7, 1996, as amended at 78 FR 58822, Sept. 24, 2013]
Questions
What does 21 CFR 820.120 require?
Required manufacturers to control labeling by keeping labels legible and attached, having a designated person inspect and document release before use, preventing mixups in storage and operations, recording labels in the DHR, and carrying control numbers through distribution.
How do FDA investigators word a 820.120 observation?
The most common opening is: “Procedures to control labeling activities have not been established.”
Which sections are cited alongside 820.120?
In the same 483s, investigators most often also cite 820.198 (Complaint files), 820.100 (Corrective and preventive action), 820.184 (Device history record), 820.30 (Design controls).