21 CFR 211.44: Lighting
Requires drug manufacturers to provide adequate lighting in all areas of their facilities so operations, inspections, and cleaning can be performed properly.
Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals · Subpart C, Buildings and Facilities
How FDA words it
The opening lines investigators use most when they cite 211.44, from the 483s we hold.
Adequate lighting is not provided in all areas.Most used
Recent 483s citing 211.44
- Shouguang Fukang Pharmaceut ical Co · Shouguang City, Shandong, ChinaAdequate lighting is not provided in all areas… Feb 21, 2025
- LAURUS LABS LIMITED · Anakapalli, Andhra Pradesh, IndiaAdequate lighting is not provided in all areas… Oct 28, 2022
- C. O. Truxton Inc · Bellmawr, New JerseyAdequate lighting is not provided in all areas… Jun 1, 2017
- TEVA Animal Health · Saint Joseph, MissouriAdequate lighting is not provided in all areas… Apr 21, 2009
- Care-Tech Labs Inc. · Saint Louis, MissouriAdequate lighting is not provided in 'all areas… May 22, 2008
The regulation text
§ 211.44 Lighting.
Adequate lighting shall be provided in all areas.
Questions
What does 21 CFR 211.44 require?
Requires drug manufacturers to provide adequate lighting in all areas of their facilities so operations, inspections, and cleaning can be performed properly.
How do FDA investigators word a 211.44 observation?
The most common opening is: “Adequate lighting is not provided in all areas.”
Which sections are cited alongside 211.44?
In the same 483s, investigators most often also cite 211.22 (Responsibilities of quality control unit), 211.100 (Written procedures; deviations), 211.166 (Stability testing), 211.67 (Equipment cleaning and maintenance).