Suppliers / Kenvue Brands

Kenvue Brands

United States Updated 9 July 2026

Kenvue Brands is an API and finished-dose manufacturer based in United States. It holds 2 active US drug master files. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 2 April 2026 as NAI.

2
active US DMFs
0
valid CEPs
2
registered plants 2 with an FDA FEI number
32
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 2 April 2026 NAI US FDA
  • 10 February 2026 VAI US FDA
  • 27 January 2023 NAI US FDA
  • 7 October 2022 NAI US FDA
  • 3 May 2021 NAI US FDA
  • 7 July 2017 VAI US FDA
  • 9 December 2016 NAI US FDA
  • 21 September 2015 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Lititz, United States 2510770
Fort Washington, United States 2510184

What they file, and where

Molecule Regulators Docs
Nicotine US FDA 2

Also appears on these molecule pages

Cetirizine finished dose Famotidine finished dose Ibuprofen finished dose Loperamide finished dose Minoxidil finished dose Naphazoline finished dose Nicotine API Oxymetazoline finished dose Pseudoephedrine finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 32 2

Questions about Kenvue Brands

Does Kenvue Brands hold a US DMF or a CEP?
Kenvue Brands holds 2 active US drug master files. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Kenvue Brands FDA-registered?
2 sites operated by Kenvue Brands carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Kenvue Brands's last inspection go?
The most recent inspection on record closed on 2 April 2026 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file.
Where does Kenvue Brands manufacture?
2 registered sites are on record, in United States (Lititz and Fort Washington). Every site is listed on this page with the register it came from.
What does Kenvue Brands make?
1 molecule is on record against Kenvue Brands, including Nicotine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Kenvue Brands's GMP?
Current GMP certificates are on record from US FDA. GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Open risk flags

  • 95 active litigation matters are on record.
  • The most recent inspection outcome was NAI, on 2 April 2026.

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates