Arca
Skip to content

21 CFR 211.101

Component addition checked by 2nd person

  • Inspections citing it: 154
  • Of those classified, ended OAI: 28%
  • 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.

211.101(d)
88 · Component addition checked by 2nd person
211.101(b)
34 · Measured components for manufacturing
211.101(a)
17 · Batches Formulated to less than 100%
211.101(c)
15 · Weighing/measuring/subdividing supervision

Regulation Text

eCFR did not answer; open it on eCFR

Open 21 CFR 211.101 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

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.