21 CFR 211.134 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (§ 200.5 To § 299.5) — Food And Drug Administration, Department Of Health And Human Services (Continued) (§ 200.5 To § 299.5) — Drugs: General (§ 200.5 To § 299.5) — Current Good Manufacturing Practice For Finished Pharmaceuticals (§ 211.1 To § 211.208) — Packaging And Labeling Control (§ 211.122 To § 211.137) — Drug product inspection.

(a) Packaged and labeled products shall be examined during finishing operations to provide assurance that containers and packages in the lot have the correct label.

(b) A representative sample of units shall be collected at the completion of finishing operations and shall be visually examined for correct labeling.

(c) Results of these examinations shall be recorded in the batch production or control records.