21 CFR 207.30
21 CFR 207.30 is the regulation in 21 CFR Part 207, Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs, and the National Drug Code. Since 2021, 3 FDA warning letters have cited it.
- Letters citing it
- 3 since 2021
- Jan 1 to Oct 30, 2026
- 1 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 201.128, in 3 letters
- Closed out
- 67% of these letters have a published close-out
Letters citing it, by year issued
All are drug letters. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
The regulation
The text of this section is not in the saved copy.
Text from eCFR.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 207.30.
Latest letters citing it
The 3 letters citing 21 CFR 207.30 that FDA posted most recently.
- DrugsView InvaDerm, Inc.Unapproved new drug products (InvaDerm products)IssuedJun 3, 2026PostedJun 16, 2026
- DrugsView Azurity Pharmaceuticals, Inc.Prescription drug products referred to as FIRST Unit-of-Use KitsIssuedSep 20, 2024PostedSep 24, 2024
- DrugsView Quality CDMO, Inc.Sodium Sulfacetamide 10% Wash, Sodium Sulfacetamide 10% and Sulfur 5% Cleanser, Selenium Sulfide 2.25% Shampoo, Urea 40% Cream, and…IssuedSep 11, 2024PostedSep 17, 2024
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Counts include every citation in a letter, as the Letters filter does. How this database is built.