21 CFR 211.184: Component, drug product container, closure, and labeling records
Requires manufacturers to keep records for components, containers, closures, and labeling covering receipt details, test results, inventory and use reconciliation traceable to batches, label review for conformity, and disposition of rejected materials.
Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals · Subpart J, Records and Reports
How FDA words it
The opening lines investigators use most when they cite 211.184, from the 483s we hold.
Records fail to include an individual inventory record of each component, reconciliation of the use of each component, drug product container and drug product closure with sufficient information to allow determination of any…Most used
There is no documentation of the examination and review of labels and labeling for conformity with established specifications.211.184(d)
Cited over time
483s citing 211.184, by yearMost citations in 2018. Bars are relative to the busiest year. *2026 to date.
Years shown: 2017 to 2026. The busiest year was 2018.
Recent 483s citing 211.184
- Hit Promotional Products Inc. · Saint Petersburg, FloridaThere is no documentation of the examination and review of labels and labeling for… Jan 28, 2026
- RK PHARMA INC. · Pearl River, New YorkRecords do not include the disposition of rejected drug product containers… May 31, 2024
- Morgan Gallacher · Santa Fe Springs, CaliforniaRecords fail to include an individual inventory record of each reconciliation of… Oct 26, 2023
- Sugar Foods Corporation · Sun Valley, CaliforniaRecords fail to include an individual inventory record of each component,… Dec 13, 2022
- ITM Medical Isotopes GmbH · Neufahrn b. Freising, Bayern, GermanyDocumentation of inspection on incoming materials was incomplete,… Jan 14, 2022
The regulation text
§ 211.184 Component, drug product container, closure, and labeling records.
These records shall include the following:
(a)The identity and quantity of each shipment of each lot of components, drug product containers, closures, and labeling; the name of the supplier; the supplier's lot number(s) if known; the receiving code as specified in § 211.80; and the date of receipt. The name and location of the prime manufacturer, if different from the supplier, shall be listed if known.
(b)The results of any test or examination performed (including those performed as required by § 211.82(a), § 211.84(d), or § 211.122(a)) and the conclusions derived therefrom.
(c)An individual inventory record of each component, drug product container, and closure and, for each component, a reconciliation of the use of each lot of such component. The inventory record shall contain sufficient information to allow determination of any batch or lot of drug product associated with the use of each component, drug product container, and closure.
(d)Documentation of the examination and review of labels and labeling for conformity with established specifications in accord with §§ 211.122(c) and 211.130(c).
(e)The disposition of rejected components, drug product containers, closure, and labeling.
Questions
What does 21 CFR 211.184 require?
Requires manufacturers to keep records for components, containers, closures, and labeling covering receipt details, test results, inventory and use reconciliation traceable to batches, label review for conformity, and disposition of rejected materials.
How do FDA investigators word a 211.184 observation?
The most common opening is: “Records fail to include an individual inventory record of each component, reconciliation of the use of each component, drug product container and drug product closure with sufficient information to allow determination of any…”
Which sections are cited alongside 211.184?
In the same 483s, investigators most often also cite 211.192 (Production record review), 211.67 (Equipment cleaning and maintenance), 211.188 (Batch production and control records), 211.100 (Written procedures; deviations).