21 CFR Citation Finder

Paste an SOP, a Form 483, a warning letter or an audit report. The 21 CFR Citation Finder pulls out every reference, whether it is written "21 CFR 211.192", "§211.68(b)" or just "820.30(g)", and shows how often FDA cites each Part 211 section.

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77 words6 cfr citations

Observation 1: The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed, as required by 21 CFR 211.22(d). Observation 2: There is a failure to thoroughly review any unexplained discrepancy, 21 CFR 211.192. Observation 3: Equipment cleaning records are incomplete (§211.67(b)). Laboratory controls do not include scientifically sound specifications, 21 CFR 211.160(b). Device note: complaint files under 21 CFR 820.198 were reviewed, and MDR procedures under 21 CFR Part 803.

Flagged, and what to write instead

21 CFR 211.22(d)21 CFR 211.22: cited at 352 of 774 Part 211 drug inspections (45.5%).
21 CFR 211.19221 CFR 211.192: cited at 296 of 774 Part 211 drug inspections (38.2%).
§211.67(b)21 CFR 211.67: cited at 244 Part 211 drug inspections.
21 CFR 211.160(b)21 CFR 211.160: cited at 216 Part 211 drug inspections.
21 CFR 820.198CFR citation.
21 CFR Part 803CFR citation.

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How to use the 21 CFR Citation Finder

Step 1
Paste an SOP, Form 483, warning letter or report, or open the .docx.
Step 2
Every 21 CFR citation is highlighted and listed.
Step 3
See how often FDA cites each Part 211 section, then save the list.

What the 21 CFR Citation Finder pulls out

Any way the citation is written

"21 CFR 211.192", "§211.68(b)", "21 CFR Part 11" and bare sections with a paragraph like 820.30(g).

How often FDA cites it

Part 211 sections come with the number of drug inspections where FDA cited them, from the Atlas Form 483 dataset.

Drugs, devices, biologics, labs

Title 21 Parts 1, 11, 58, 210, 211, 212, 314, 600, 601, 606, 803, 806 and 820.

Your document stays on your computer

The check runs in your browser tab. No upload, no copy on a server, and no analytics on the text box.

Opens Word files

Drop in a .docx, .txt or .md file, or paste from a PDF or your document system. Word files are unzipped and read locally.

Free, no account

Use it as often as you like. We only ask for an email if you want to save the review as a PDF.

What can you do with a list of CFR citations?

Check that your SOP's reference section matches the regulations its steps rely on. Map a Form 483 or warning letter to the exact sections FDA cited before you draft the response. Or build a regulatory matrix for a new site from the procedures you already have.

Which 21 CFR 211 sections does FDA cite most?

From the Atlas Form 483 citation dataset: 774 drug inspections citing 21 CFR Part 211, January 2025 to September 2026. Each count is the number of inspections where the section appeared at least once.

Section	How often FDA cited it
21 CFR 211.22	cited at 352 of 774 Part 211 drug inspections (45.5%)
21 CFR 211.192	cited at 296 of 774 Part 211 drug inspections (38.2%)
21 CFR 211.67	cited at 244 Part 211 drug inspections
21 CFR 211.100	cited at 224 Part 211 drug inspections
21 CFR 211.160	cited at 216 Part 211 drug inspections
21 CFR 211.84	cited at 169 Part 211 drug inspections
21 CFR 211.68	cited at 132 Part 211 drug inspections
21 CFR 211.166	cited at 132 Part 211 drug inspections
21 CFR 211.165	cited at 102 Part 211 drug inspections
21 CFR 211.113	cited at 98 Part 211 drug inspections (sterile, 211.113(b))
21 CFR 211.180	cited at 71 Part 211 drug inspections (annual product review, 211.180(e))

Does my document get uploaded?

No. Your browser does all the work. The text you paste and the file you open stay on your computer, the checker reads them in memory, and closing the tab wipes them. Atlas never receives a word of it.

We also switched off session recording and analytics on the tool itself, so nothing you type reaches a tracking script. You can check this yourself: open the network tab in your browser's developer tools, run a check, and watch nothing leave. Your company's rules on where confidential documents can be opened still apply.

Frequently asked questions

What is 21 CFR?

Title 21 of the Code of Federal Regulations, where FDA's rules live. Part 11 covers electronic records and signatures, Parts 210 and 211 drug CGMP, Part 820 the device quality system (QMSR), Part 803 medical device reporting, and Parts 600 to 606 biologics.

What is the most cited 21 CFR section on Form 483s?

For drugs, 21 CFR 211.22, the quality control unit's responsibilities. It appeared at 352 of 774 Part 211 drug inspections in the Atlas dataset from January 2025 to September 2026. 211.192, production record review and investigations, came second at 296.

What does 21 CFR 211 cover?

CGMP for finished drugs: organization and personnel, buildings, equipment, components, production and process controls, packaging and labeling, holding and distribution, laboratory controls, records and reports, and returned or salvaged drugs.

How do I cite a CFR section?

Title, CFR, then part and section: 21 CFR 211.192. Add the paragraph in parentheses when it matters, as in 21 CFR 211.68(b). The section sign form, §211.192, is common too.

Where is the official text of 21 CFR?

The eCFR, the Electronic Code of Federal Regulations from the Office of the Federal Register, is updated continuously. The annual print edition sits on govinfo.

Can I paste a Form 483?

Yes. Paste the observation text and the finder lists each section it cites. Form 483s often describe the requirement without a citation, while warning letters usually include one.

Does it find citations to other titles?

No. It looks for the Title 21 parts used in drug, biologic, device and lab regulation. ISO standards, EU GMP chapters and other CFR titles are not extracted.

Is the text uploaded?

No. Extraction runs in your browser and nothing goes to Atlas. Analytics and session recording are off on the tool.

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