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21 CFR 606.100

Establish, maintain and follow manufacturing SOPs

  • Inspections citing it: 1,703
  • Of those classified, ended OAI: 3%
  • 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.

606.100(b)
1,076 · Establish, maintain and follow manufacturing SOPs
606.100(c)
387 · Thorough investigations
606.100(b)(15)
60 · Schedules and procedures for equipment & calibration
606.100(b)(10)
31 · Controlling storage temperatures
606.100(b)(14)
24 · QC procedures for supplies and reagents
606.100(b)(21)
23 · Donor notification
606.100(b)(1)
20 · Donor criteria
606.100(b)(9)
14 · Written methods for investigating adverse reactions

Regulation Text

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Open 21 CFR 606.100 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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