US · 21 CFR
Findings by 21 CFR section
Findings that cite sections of the US GMP regulations (21 CFR Parts 210·211), grouped by section, with real cases showing what was actually cited. Only sections with at least 3 cases are listed.
21 CFR 210.1
Status of current good manufacturing practice regulations.
29 documents
21 CFR 211.100
Written procedures; deviations.
189 documents
21 CFR 211.101
Charge-in of components.
3 documents
21 CFR 211.110
Sampling and testing of in-process materials and drug products.
8 documents
21 CFR 211.113
Control of microbiological contamination.
86 documents
21 CFR 211.125
Labeling issuance.
4 documents
21 CFR 211.130
Packaging and labeling operations.
5 documents
21 CFR 211.137
Expiration dating.
20 documents
21 CFR 211.142
Warehousing procedures.
3 documents
21 CFR 211.160
General requirements.
89 documents
21 CFR 211.165
Testing and release for distribution.
143 documents
21 CFR 211.166
Stability testing.
130 documents
21 CFR 211.167
Special testing requirements.
7 documents
21 CFR 211.170
Reserve samples.
4 documents
21 CFR 211.180
General requirements.
32 documents
21 CFR 211.182
Equipment cleaning and use log.
3 documents
21 CFR 211.186
Master production and control records.
4 documents
21 CFR 211.188
Batch production and control records.
61 documents
21 CFR 211.192
Production record review.
130 documents
21 CFR 211.194
Laboratory records.
28 documents
21 CFR 211.198
Complaint files.
14 documents
21 CFR 211.22
Responsibilities of quality control unit.
180 documents
21 CFR 211.25
Personnel qualifications.
19 documents
21 CFR 211.28
Personnel responsibilities.
5 documents
21 CFR 211.34
Consultants.
212 documents
21 CFR 211.42
Design and construction features.
77 documents
21 CFR 211.56
Sanitation.
8 documents
21 CFR 211.58
Maintenance.
10 documents
21 CFR 211.63
Equipment design, size, and location.
16 documents
21 CFR 211.67
Equipment cleaning and maintenance.
76 documents
21 CFR 211.68
Automatic, mechanical, and electronic equipment.
33 documents
21 CFR 211.80
General requirements.
4 documents
21 CFR 211.84
Testing and approval or rejection of components, drug product containers, and closures.
179 documents
21 CFR 211.94
Drug product containers and closures.
3 documents
Section titles are as written in the US Code of Federal Regulations. Counts are computed automatically from published documents, and findings are extracted automatically from the regulator's published documents. Each section page links directly to the official source.
