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21 CFR 211.125

Strict control not exercised over labeling issued

  • Inspections citing it: 467
  • Of those classified, ended OAI: 22%
  • Last cited: FY2026

Inspections Citing It by Fiscal Year

Sites in and outside the US, FY2017 to Oct 20, 2026.

Paragraphs Cited

As FDA posts them, all years.

211.125(a)
282 · Strict control not exercised over labeling issued
211.125(f)
130 · Procedures Written and Followed
211.125(c)
24 · Label reconciliation discrepancies evaluation/investigation
211.125(b)
19 · Examination of issued labels
211.125(d)
12 · Destruction of excess labels with lot numbers

Regulation Text

eCFR did not answer; open it on eCFR

Open 21 CFR 211.125 on eCFR

Recently Cited Sites

Newest inspections citing this section; each opens the site

Counts are inspections with posted citations that cite any paragraph of the section, once per inspection, from FDA's Data Dashboard. OAI share is over inspections FDA finally classified. Text from eCFR, the official online CFR. FDA Data Dashboard and eCFR

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