US FDA 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.

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.

A drug is misbranded under section 502(f)(1) of the FD&C Act if its labeling fails to bear adequate directions for use. "Adequate directions for use" means directions under which a layperson can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act include those that, because of their toxicity or other potentiality for harmful effect, or the method of their use, or the…