21 CFR 211.130: Packaging and labeling operations

Manufacturers must follow written procedures ensuring correct labels and packaging materials are used, including separating operations, controlling unlabeled containers, assigning lot numbers, examining materials beforehand, and documenting line clearance inspections in batch records.

Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals · Subpart G, Packaging and Labeling Control

of drug-manufacturing 483s since 2023 cite this section at least once

How FDA words it

The opening lines investigators use most when they cite 211.130, from the 483s we hold.

The drug product is not identified with a lot or control number that permits the determination of the history of the manufacture and control of the batch.Most used

Procedures designed to assure that correct labels, labeling, and packaging materials are used for drug products are not written and followed.

Inspection of the packaging and labeling facilities immediately before use is not done to assure that all drug products have been removed from previous operations.211.130(e)

Cited over time

483s citing 211.130, by year

Most citations in 2018. Bars are relative to the busiest year. *2026 to date.

Recent 483s citing 211.130

See all 483s citing 211.130

The regulation text

§ 211.130 Packaging and labeling operations.

There shall be written procedures designed to assure that correct labels, labeling, and packaging materials are used for drug products; such written procedures shall be followed. These procedures shall incorporate the following features:

(a)Prevention of mixups and cross-contamination by physical or spatial separation from operations on other drug products.

(b)Identification and handling of filled drug product containers that are set aside and held in unlabeled condition for future labeling operations to preclude mislabeling of individual containers, lots, or portions of lots. Identification need not be applied to each individual container but shall be sufficient to determine name, strength, quantity of contents, and lot or control number of each container.

(c)Identification of the drug product with a lot or control number that permits determination of the history of the manufacture and control of the batch.

(d)Examination of packaging and labeling materials for suitability and correctness before packaging operations, and documentation of such examination in the batch production record.

(e)Inspection of the packaging and labeling facilities immediately before use to assure that all drug products have been removed from previous operations. Inspection shall also be made to assure that packaging and labeling materials not suitable for subsequent operations have been removed. Results of inspection shall be documented in the batch production records.

[43 FR 45077, Sept. 29, 1978, as amended at 58 FR 41354, Aug. 3, 1993]

Questions

What does 21 CFR 211.130 require?

How often is 211.130 cited in Form 483s?

It appears in about 1% of the drug-manufacturing 483s we hold from 2023 onward.

How do FDA investigators word a 211.130 observation?

The most common opening is: “The drug product is not identified with a lot or control number that permits the determination of the history of the manufacture and control of the batch.”

Which sections are cited alongside 211.130?

In the same 483s, investigators most often also cite 211.192 (Production record review), 211.22 (Responsibilities of quality control unit), 211.67 (Equipment cleaning and maintenance), 211.100 (Written procedures; deviations).