QMSR Section 820.45 (Device Labeling and Packaging Controls)

Adds labeling and packaging controls beyond ISO 13485 clause 7.5.1. A manufacturer must document procedures for the integrity, inspection, storage, and operations of labeling and packaging, and examine labeling for accuracy before release or storage.

What each paragraph requires

820.45(a)

Examine labeling and packaging for accuracy before release or storage. The examination covers the correct UDI or UPC or other identification, the expiration date, storage instructions, handling instructions, and any additional processing instructions.

820.45(b)

Document the release of labeling for use under ISO 13485 clause 4.2.5.

820.45(c)

Establish and maintain labeling and packaging operations that prevent mixups, including inspection before use, and document the inspection results under clause 4.2.5.

Where it is written

21 CFR 820.45

Also called

21 CFR 820.45, 820.45

Related terms