Labeling and packaging Findings

Reserve drug product samples are not appropriately identified, representative of each lot or batch of drug product and retained and stored under conditions consistent with product labeling.

You did not establish packaging specifications.

Strict control is not exercised over labeling issued for use in drug product labeling operations.

You did not establish specifications to ensure that you applied the specified label.

The importer did not ensure that the foreign sites use to fabricate, package/label, or test drug products met the requirements described in Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080).

Reserve drug product samples are not representative of each lot or batch of drug product and retained and stored under conditions consistent with product labeling.