21 CFR 211.134: Drug product inspection
Requires manufacturers to examine packaged drug products during finishing for correct labeling, visually check a representative sample at completion, and record the results in batch production or control records.
Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals · Subpart G, Packaging and Labeling Control
How FDA words it
The opening lines investigators use most when they cite 211.134, from the 483s we hold.
The results of the examination of the packaged and labeled products were not documented in the batch production or control records.Most used
Packaged and labeled products are not examined during finishing operations to provide assurance that containers and packages in the lot have the correct label.211.134(a)
Cited over time
483s citing 211.134, by yearMost citations in 2019. Bars are relative to the busiest year. *2026 to date.
Years shown: 2017 to 2026. The busiest year was 2019.
Recent 483s citing 211.134
- Horizon Tool Inc. · GREENSBORO, North CarolinaPackaged and labeled products are not examined during finishing operations to… Jan 16, 2025
- Medi-Fare Drug · Blacksburg, South CarolinaSamples of representative lmits were not visually examined for coITect labeling at… May 26, 2023
- New England Life Care, Inc., dba Advanced Compounding Solutions · Woburn, MassachusettsSamples of representative units were not collected and visually examined for… Apr 28, 2022
- DLC Laboratories, Inc. · Paramount, CaliforniaSamples of representative units were not visually examined for correct labeling at… Dec 12, 2019
- SCA Phannaceuticals, Inc · Little Rock, ArkansasThe results of the examination of the packaged and labeled products were not… Nov 7, 2019
The regulation text
§ 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.
Questions
What does 21 CFR 211.134 require?
Requires manufacturers to examine packaged drug products during finishing for correct labeling, visually check a representative sample at completion, and record the results in batch production or control records.
How do FDA investigators word a 211.134 observation?
The most common opening is: “The results of the examination of the packaged and labeled products were not documented in the batch production or control records.”
Which sections are cited alongside 211.134?
In the same 483s, investigators most often also cite 211.42 (Design and construction features), 211.192 (Production record review), 211.22 (Responsibilities of quality control unit), 211.67 (Equipment cleaning and maintenance).