§ 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.

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What FDA inspectors cite under § 211.134

Form FDA 483 observations citing this section, fiscal years 2009–2026 (Drugs).

• Correct labels during finishing operations 29
• Examinations documented 28
• Representative samples after completion 17

FDA guidance that cites § 211.134

• Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry: Draft Guidance for Industry draft 22 Jan 2020
• BLA for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System: Guidance for Industry 1 Mar 2014

Amendment history

Federal Register documents that created or amended this section.

• 43 FR 45077 29 Sept 1978