21 CFR 211.142: Warehousing procedures
Requires manufacturers to establish and follow written warehousing procedures that quarantine drug products until the quality control unit releases them and store them under temperature, humidity, and light conditions preserving identity, strength, quality, and purity.
Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals · Subpart H, Holding and Distribution
3%
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 211.142, from the 483s we hold.
Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality, and purity are not affected.Most used
Drug products are not stored under appropriate conditions of temperature and humidity so that their identity, strength, quality, and purity are not affected.211.142(b)
Procedures describing the warehousing of drug products are not followed.
Cited over time
483s citing 211.142, 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 211.142
- Neeyaan LLC · Cranbury, New JerseyDrug products are not stored under appropriate conditions of temperature, humidity… Jan 27, 2026
- Hood Container Corporation · Rural Hall, North CarolinaProcedures describing the warehousing of ding products are not established and… Jan 16, 2026
- US Specialty Formulations LLC · Allentown, PennsylvaniaDrug products are not stored under appropriate conditions of temperature so that… Jan 14, 2026
- Hetero Labs Limited, Unit-EX · Narasapmam Village, IndiaYour firm released finished API's and intermediates intended for the US market to… Sep 26, 2025
- Sparsha Pharma Usa Inc · Oceanside, CaliforniaProcedures describing the warehousing of drug products are not followed… Sep 4, 2025
The regulation text
§ 211.142 Warehousing procedures.
Written procedures describing the warehousing of drug products shall be established and followed. They shall include:
(a)Quarantine of drug products before release by the quality control unit.
(b)Storage of drug products under appropriate conditions of temperature, humidity, and light so that the identity, strength, quality, and purity of the drug products are not affected.
Questions
What does 21 CFR 211.142 require?
Requires manufacturers to establish and follow written warehousing procedures that quarantine drug products until the quality control unit releases them and store them under temperature, humidity, and light conditions preserving identity, strength, quality, and purity.
How often is 211.142 cited in Form 483s?
It appears in about 3% of the drug-manufacturing 483s we hold from 2023 onward.
How do FDA investigators word a 211.142 observation?
The most common opening is: “Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality, and purity are not affected.”
Which sections are cited alongside 211.142?
In the same 483s, investigators most often also cite 211.22 (Responsibilities of quality control unit), 211.67 (Equipment cleaning and maintenance), 211.160 (General requirements), 211.192 (Production record review).