21 CFR 600.14
Who must report - manufacturer
- Inspections citing it: 88
- Of those classified, ended OAI: 2%
- 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.
- 600.14(a)(1)
- 44 · Who must report - manufacturer
- 600.14(c)
- 44 · When to report
Regulation Text
eCFR did not answer; open it on eCFRRecently Cited Sites
Newest inspections citing this section; each opens the site- Sullivan Memorial Blood CenterUnited States · Jul 14, 2026
- Cantor BioConnect, Inc.United States · Mar 24, 2026
- CSL Behring GmbHGermany · Feb 18, 2026
- Bavarian Nordic A/SDenmark · Dec 9, 2025
- Nielsen Biosciences, IncUnited States · Apr 17, 2025
- Ochsner Health System Blood BankUnited States · Jul 5, 2024
- Allermed Laboratories, Inc.United States · Jan 31, 2024
- Novartis Innovative Technologies Inc.United States · Jan 26, 2024
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