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.