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21 CFR 606.140

Establishment of spec., standards, and test procedures

  • Inspections citing it: 45
  • Of those classified, ended OAI: 9%
  • Last cited: FY2025

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.

606.140(a)
19 · Establishment of spec., standards, and test procedures
606.140(b)
17 · Provisions to monitor lab test procedures & instruments
606.140(c)
9 · Adequate identification and handling of test samples

Regulation Text

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Open 21 CFR 606.140 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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