What is FDA actually citing device makers for?
An industry-wide view of inspection citations, classifications, and compliance actions — built for procurement, regulatory, and quality teams doing supplier due diligence.
Most-cited requirements
Ranked by frequency across 5,824 citations
21 CFR 820.100(a)Lack of or inadequate procedures
50521 CFR 820.198(a)Lack of or inadequate complaint procedures
46821 CFR 820.22Quality audits - auditor independence
20321 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
20221 CFR 820.30(g)Design validation- Lack of or inadequate procedures
19721 CFR 820.50Purchasing controls, Lack of or inadequate procedures
19121 CFR 820.75(a)Lack of or inadequate process validation
18921 CFR 820.184Lack of or inadequate DHR procedures
17721 CFR 803.17Lack of Written MDR Procedures
14221 CFR 820.25(b)Training - Lack of or inadequate procedures
13021 CFR 820.20(c)Management review - defined interval, sufficient frequency
12921 CFR 801.20(a)Label to bear a unique device identifier
11621 CFR 820.100(b)Documentation
11621 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
10021 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
88
Inspection outcomes
All inspections on file
Compliance actions
Warning letters and injunctions
Most common import refusal reasons
Across 10,544 refused shipments
118NOT LISTED — 502(o), 801(a)(3); MISBRANDING
5,0443280FRNMFGREG — 502(o), 801(a)(3); MISBRANDING
4,506508NO 510(K) — 801(a)(3); 502(o) Misbranding
2,692341REGISTERED — 502(o), 801(a)(3); MISBRANDING
2,1262780DEVICEGMPS — 501(h), 801(a)(1); ADULTERATION
1,535237NO PMA — 501(f)(1)(B), 801(a)(3); ADULTERATION
793477HOLES — 501(c); 801(a)(3) Adulteration
5453904
4343905
401290DE IMP GMP — 801(a)(1); NON CONFORMING MANUFACTURING PRACTICES
354479DV QUALITY — 501(c); 801(a)(3) Adulteration
323235NOT IMPACT — 501(c), 801(a)(3); ADULTERATION
163476NO REGISTR — 536(a); Failure to file initial report
873260NO ENGLISH — 502(c); 801(a)(3);Misbranding
8784RX DEVICE — 502(a),(f)(1), 801(a)(3); MISBRANDING
87