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[Code of Federal Regulations]
[Title 21, Volume 4]
[CITE: 21CFR211.134]
TITLE 21–FOOD AND DRUGS
CHAPTER I–FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C – DRUGS: GENERAL
PART 211 — CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
Subpart G – Packaging and Labeling Control
Sec. 211.134 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.
As per US Health & Human Services, the information on this page is current as of Aug. 30 2024.
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