Suppliers / Xlear

Xlear

United States Updated 9 July 2026

Xlear is a finished-dose manufacturer based in United States. It appears in 2 regulatory filings across 1 regulator, without an active US DMF or CEP on file. Its most recent recorded inspection, by US FDA, closed on 18 March 2022 as VAI.

0
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
2
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

  • 18 March 2022 VAI US FDA
  • 10 February 2017 VAI US FDA
  • 10 November 2011 VAI US FDA
  • 4 February 2010 VAI US FDA

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

Registered plants

Site FDA FEI
American Fork, United States 3010166224

Filings and GMP by regulator

Regulator Filings GMP certificates
DIGEMAPS (DO) 2 None

Questions about Xlear

Does Xlear hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Xlear. It does have 2 filings with one regulator, so it is registered, just not with the two strong registers buyers usually screen on.
Is Xlear FDA-registered?
One site operated by Xlear 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 Xlear's last inspection go?
The most recent inspection on record closed on 18 March 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Xlear manufacture?
1 registered site is on record, in United States (American Fork). Every site is listed on this page with the register it came from.
Where does Xlear file?
Filings are on record with DIGEMAPS (DO), 2 in total.

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 VAI, on 18 March 2022.

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability