A recent FDA observation makes it painfully clear that failure to control labeling and packaging can pose a significant risk to patient safety and regulatory compliance. FDA cited a foreign producer of consumer drug products for lacking written procedures to ensure correct labeling and packaging materials were used. The 483 reads as follows:
“The firm does not have a procedure describing in sufficient detail the controls employed for the issuance and reconciliation of product labeling. Labeling reconciliation was not performed…”
“The firm does not have a procedure describing the examination of packaging and labeling materials for suitability and correctness before packaging operations. Packaging and labeling materials examination and verification of correct printing of product lot number and expiration date were not documented in the batch record…”
Labeling failures directly impact the assurance that the correct product is being given to the correct patient with the correct instructions and expiration date. Label mix-ups can lead to dosage errors or therapeutic failures, risking public health.
The CFR reference is clear on this point. According to 21 CFR §211.125 and 21 CFR §211.130:
“Procedures shall be used to reconcile the quantities of labeling issued, used, and returned, and shall require evaluation of discrepancies found between the quantity of drug product finished and the quantity of labeling issued…”
Labels are not just stickers. Labels are regulated, serialized identifiers, and each label that is issued must be accounted for. Unused labels are highly sensitive items that must either be reconciled or securely destroyed and documented.
FDA continues to emphasize expectations for written, verifiable systems that support end-to-end control of labeling operations. Where procedures are vague or missing, and batch records lack critical documentation, there will be non-compliance consequences.
