Glossary
Packaging Material
Any material used in packaging a medicine, other than the outer packaging used for transport.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
-
Your firm failed to establish a quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)).
FDA · FDA Warning Letter · 2021-04-13 -
There is a lack of written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, examination and testing of labeling and packaging materials.
FDA · FDA 483 · 2024-01-17 -
Labeling or packaging materials which did not meet written specifications were not rejected to prevent their use in operations for which they are unsuitable.
FDA · FDA 483 · 2021-04-21
