21 CFR 211.134 - Drug Product Inspection

What it says

Packaging and labeling facilities must be inspected immediately before use to ensure all drug products have been removed from previous operations, with adequate examination of a representative sample of finished, labeled units conducted during the finishing phase to provide assurance that labeling is correct.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• This provision requires an in-process check specifically during packaging and labeling operations, distinct from the batch record documentation and reconciliation checks that occur separately.
• The pre-use facility inspection component connects directly to line clearance expectations under 211.130, confirming no product or labeling from a previous operation remains before a new one begins.
• Representative sampling during the finishing phase is meant to catch labeling errors in near-real time, while the packaging run is still ongoing, rather than only through end-of-run reconciliation.

What FDA inspectors look for

• Whether documented facility inspection immediately precedes each packaging and labeling operation, with evidence the previous product was fully cleared.
• Whether in-process sampling and examination during packaging actually occurs at a meaningful frequency throughout the run, not just at the very start or end.
• Whether findings from in-process inspection, when a discrepancy is caught, are documented and investigated rather than quietly corrected without a record.

Related regulations