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21 CFR 211.194

Complete test data included in records

  • Inspections citing it: 1,184
  • Of those classified, ended OAI: 27%
  • 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.

211.194(a)
330 · Complete test data included in records
211.194(a)(8)
221 · Second person sign off
211.194(a)(4)
159 · Complete Test Data
211.194(a)(2)
138 · Suitability of testing methods verified
211.194(d)
71 · Laboratory equipment calibration records
211.194(c)
69 · Testing and standardization of standards et. al.
211.194(a)(5)
47 · Calculations performed are in the records
211.194(a)(1)
41 · Sample identification and other information

Regulation Text

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Open 21 CFR 211.194 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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