A company recently received this 483 observation:
….. Establishment of the reliability of the container and closure supplier’s report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.
Specifically, when I requested the firm’s management to review the release data on the packaging containers and closures, your director stated that the jars had been accepted without COA from the vendor and no other testing had been performed.
For more observations pertaining to packaging and labeling, see our new issue 1059 available today. It has observations pertaining to quality systems, manufacturing controls, and medical devices.