21 CFR 211.130
Packaging and labeling operations
21 CFR 211.130 is the regulation titled “Packaging and labeling operations” in 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals. Since 2021, 8 FDA warning letters have cited it.
- Letters citing it
- 8 since 2021
- Jan 1 to Oct 30, 2026
- 2 against 1 on the same dates in 2025
- Most often cited with
- 21 CFR 211.22, in 8 letters
- Closed out
- 13% of these letters have a published close-out
Letters citing it, by year issued
Most are drug letters (7 of 8). 2026 runs to Oct 30, 2026. Pick a year to see its letters.
What FDA writes when it cites it
The finding headings that cite 21 CFR 211.130 most often, as written in the letters.
- 2 lettersYour firm failed to establish an adequate quality unit (QU) with the responsibilities and authority to oversee the manufacture of drug products. For example, you failed to ensure:
- 1 letterYour firm failed to establish and follow written procedures designed to assure that correct labels, labeling, and packaging are used for drug products. (21 CFR 211.130)
The regulation
Read the text of 21 CFR 211.130 (eCFR, as of Sep 1, 2026)
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]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 211.130.
- 21 CFR 211.22Responsibilities of quality control unit8 letters cite both
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures6 letters cite both
- 21 CFR 211.100Written procedures; deviations5 letters cite both
- 21 CFR 211.165Testing and release for distribution5 letters cite both
- 21 CFR 211.166Stability testing3 letters cite both
- 21 CFR 211.188Batch production and control records3 letters cite both
- 21 CFR 211.192Production record review3 letters cite both
- 21 CFR 211.198Complaint files3 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 211.130 that FDA posted most recently.
- DrugsView Jiangmen Shuizirun Sanitary Articles Co., Ltd.OTC drug products labeled as sterileIssuedSep 23, 2026PostedOct 13, 2026
- DrugsView Yangzhou H&R Plastic Daily Chemical Co., Ltd.over-the-counter (b)(4) drug productIssuedMar 18, 2026PostedMar 24, 2026
- BiologicsView Chara Biologics, Inc.CharaExo, CharaCore, CharaOmniIssuedJan 17, 2025PostedJan 28, 2025
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Counts include every citation in a letter, as the Letters filter does. How this database is built.