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FDA 지적 조항
FDA 가 지적을 낸 실사 가운데 어느 조항이 몇 번 인용됐는지 봅니다. 한 실사가 같은 조항을 여러 번 적어도 1건으로 셉니다.
2,709지적이 나온 실사 (FY2021~FY2026)
| # | 조항 | FDA 표기 | 실사 | 비율 | 연도별 | |
|---|---|---|---|---|---|---|
| 1 | 21 CFR 211.22(d) | Procedures not in writing, fully followed | 819 | 30% | ||
| 2 | 21 CFR 211.192 | Investigations of discrepancies, failures | 783 | 29% | ||
| 3 | 21 CFR 211.100(a) | Absence of Written Procedures | 542 | 20% | ||
| 4 | 21 CFR 211.160(b) | Scientifically sound laboratory controls | 452 | 17% | ||
| 5 | 21 CFR 211.68(b) | Computer control of master formula records | 362 | 13% | ||
| 6 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance | 315 | 12% | ||
| 7 | 21 CFR 211.113(b) | Procedures for sterile drug products | 303 | 11% | ||
| 8 | 21 CFR 211.63 | Equipment Design, Size and Location | 276 | 10% | ||
| 9 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) | 275 | 10% | ||
| 10 | 21 CFR 211.67(b) | Written procedures not established/followed | 259 | 9.6% | ||
| 11 | 21 CFR 211.166(a) | Lack of written stability program | 258 | 9.5% | ||
| 12 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures | 243 | 9.0% | ||
| 13 | 21 CFR 211.22(a) | Lack of quality control unit | 220 | 8.1% | ||
| 14 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance | 179 | 6.6% | ||
| 15 | 21 CFR 211.165(a) | Testing and release for distribution | 173 | 6.4% | ||
| 16 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done | 163 | 6.0% | ||
| 17 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component | 151 | 5.6% | ||
| 18 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System | 148 | 5.5% | ||
| 19 | 21 CFR 211.100(b) | SOPs not followed / documented | 147 | 5.4% | ||
| 20 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs | 141 | 5.2% | ||
| 21 | 21 CFR 211.160(a) | Following/documenting laboratory controls | 135 | 5.0% | ||
| 22 | 21 CFR 211.198(a) | Complaint Handling Procedure | 117 | 4.3% | ||
| 23 | 21 CFR 211.188 | Prepared for each batch, include complete information | 106 | 3.9% | ||
| 24 | 21 CFR 211.113(a) | Procedures for non-sterile drug products | 99 | 3.7% | ||
| 25 | 21 CFR 211.142(b) | Storage under appropriate conditions | 94 | 3.5% | ||
| 26 | 21 CFR 211.165(e) | Test methods | 94 | 3.5% | ||
| 27 | 21 CFR 211.42(c)(10)(v) | Cleaning System | 94 | 3.5% | ||
| 28 | 21 CFR 211.58 | Buildings not maintained in good state of repair | 93 | 3.4% | ||
| 29 | 21 CFR 211.170(b) | Annual visual exams of drug products | 84 | 3.1% | ||
| 30 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action | 82 | 3.0% |
비율은 지적이 나온 실사 중 그 조항이 인용된 몫입니다(지적 없는 실사는 분모에서 빠짐). 막대는 FY2021~FY2026 해마다의 비율이고, 최근 연도는 FDA 게시가 늦어 적게 보일 수 있습니다.
조항 표기는 FDA 원문 그대로입니다. 인용 빈도이며 위반 판단이 아닙니다.
출처: FDA Data Dashboard - Inspections Citations, 2026-11-08 기준.