21 CFR 211.100: Written procedures; deviations
Manufacturers must establish written production and process control procedures approved by the quality control unit, follow them while documenting execution at the time of performance, and record and justify any deviations.
Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals · Subpart F, Production and Process Controls
27%
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 211.100, from the 483s we hold.
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.Most used
Written production and process control procedures are not followed in the execution of production and process control functions.211.100(b)
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to…211.100(a)
Cited over time
483s citing 211.100, by yearMost citations in 2024. Bars are relative to the busiest year. *2026 to date.
Years shown: 2017 to 2026. The busiest year was 2024.
Recent 483s citing 211.100
- OPS International Inc. dba Olympia Pharmaceuticals · Orlando, FloridaWritten production and process control procedures are not followed in the execution… Sep 3, 2026
- Sincerus Florida, LLC dba SKNV · Pompano Beach, FloridaYour firm failed to establish adequate written procedures for production and… May 29, 2026
- Shilpa Medicare Limited · Bengaluru, Karnataka, IndiaYour firm failed to establish adequate written procedures for production and… May 29, 2026
- Fresenius Kabi USA, LLC · Grand Island, New YorkYour firm failed to establish adequate written procedures for production and… May 14, 2026
- Alkem Laboratories Limited · Daman and Diu, IndiaThere are no written procedures for production and process controls designed to… May 1, 2026
The regulation text
§ 211.100 Written procedures; deviations.
(a)There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall include all requirements in this subpart. These written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control unit.
(b)Written production and process control procedures shall be followed in the execution of the various production and process control functions and shall be documented at the time of performance. Any deviation from the written procedures shall be recorded and justified.
Questions
What does 21 CFR 211.100 require?
Manufacturers must establish written production and process control procedures approved by the quality control unit, follow them while documenting execution at the time of performance, and record and justify any deviations.
How often is 211.100 cited in Form 483s?
It appears in about 27% of the drug-manufacturing 483s we hold from 2023 onward, which makes it one of the ten most-cited sections in those 483s.
How do FDA investigators word a 211.100 observation?
The most common opening is: “There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.”
Which sections are cited alongside 211.100?
In the same 483s, investigators most often also cite 211.192 (Production record review), 211.67 (Equipment cleaning and maintenance), 211.22 (Responsibilities of quality control unit), 211.160 (General requirements).