Suppliers / Intersect ENT

Intersect ENT

United States Updated 9 July 2026

Intersect ENT is a finished-dose manufacturer based in United States. It appears in 1 regulatory filing across 1 regulator, without an active US DMF or CEP on file. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 7 August 2025 as NAI.

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

Inspection history

  • 7 August 2025 NAI US FDA
  • 6 March 2019 VAI US FDA
  • 11 December 2012 NAI US FDA
  • 9 May 2011 VAI US FDA

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

Registered plants

Site FDA FEI
Menlo Park, United States 3008301917

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 1 1

Questions about Intersect ENT

Does Intersect ENT hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Intersect ENT. It does have 1 filing with one regulator, so it is registered, just not with the two strong registers buyers usually screen on.
Is Intersect ENT FDA-registered?
One site operated by Intersect ENT carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Intersect ENT's last inspection go?
The most recent inspection on record closed on 7 August 2025 as NAI (No Action Indicated: nothing objectionable was found). 4 inspections are on file.
Where does Intersect ENT manufacture?
1 registered site is on record, in United States (Menlo Park). Every site is listed on this page with the register it came from.
Which regulators recognise Intersect ENT'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

  • The most recent inspection outcome was NAI, on 7 August 2025.

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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