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21 CFR 211.188

Prepared for each batch, include complete information

  • Inspections citing it: 1,450
  • 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.

211.188
586 · Prepared for each batch, include complete information
211.188(b)(8)
179 · Labeling control records including specimens or copies
211.188(b)
164 · Batch production and Batch Control Record Requirements
211.188(a)
72 · Accurate reproduction
211.188(b)(11)
71 · Identification of persons involved, each significant step
211.188(b)(2)
62 · Identity of major equipment and lines used
211.188(b)(7)
57 · Actual yield, % of theoretical yield
211.188(b)(12)
55 · Investigations made into any unexplained discrepancy

Regulation Text

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Open 21 CFR 211.188 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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