21 CFR 820.130: Device packaging
Manufacturers had to design and construct device packaging and shipping containers so the device is protected from alteration or damage during normal processing, storage, handling, and 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 820.130, from the 483s we hold.
Device packaging and/or shipping containers are not designed and constructed to protect the device from alteration or damage during processing, storage, handling, and distribution.Most used
Recent 483s citing 820.130
- BC3 TECHNOLOGIES · Baltimore, MarylandDevice packaging and/or shipping containers are not designed and constructed to… Nov 26, 2024
- Boehringer Ingelheim Fremont, Inc. · Fremont, CaliforniaDevice packaging and/or shipping containers are not designed and constructed to… Aug 24, 2018
- Zimmer Biomet, Inc. · Warsaw, IndianaDevice packaging an d/or shipping containers are not designed an d constrncted to… Oct 16, 2017
- Analytical Control Systems, Inc · Fishers, IndianaDevice packaging and/or shipping containers are not designed and constructed to… Feb 29, 2016
- Zimmer Biomet, Inc · Warsaw, IndianaDevice packaging and/or shipping containers are not designed and constructed to… Nov 20, 2015
The regulation text
§ 820.130 Device packaging. As published before it was replaced.
Each manufacturer shall ensure that device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution.
Questions
What does 21 CFR 820.130 require?
Manufacturers had to design and construct device packaging and shipping containers so the device is protected from alteration or damage during normal processing, storage, handling, and distribution.
How do FDA investigators word a 820.130 observation?
The most common opening is: “Device packaging and/or shipping containers are not designed and constructed to protect the device from alteration or damage during processing, storage, handling, and distribution.”
Which sections are cited alongside 820.130?
In the same 483s, investigators most often also cite 820.198 (Complaint files), 820.70 (Production and process controls), 820.75 (Process validation), 820.100 (Corrective and preventive action).