Suppliers / Elite Laboratories

Elite Laboratories

United States 1 employees Updated 9 July 2026

Elite Laboratories is a finished-dose manufacturer based in United States. It appears in 24 regulatory filings 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 1 August 2025 as VAI.

0
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
24
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 1 August 2025 VAI US FDA
  • 13 March 2020 VAI US FDA
  • 21 January 2020 NAI US FDA
  • 2 February 2018 NAI US FDA
  • 4 December 2017 NAI US FDA
  • 24 April 2017 VAI US FDA
  • 2 February 2016 OAI US FDA
  • 3 June 2014 VAI US FDA

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

Registered plants

Site FDA FEI
Northvale, United States 3002644678

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 24 1

Questions about Elite Laboratories

Does Elite Laboratories hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Elite Laboratories. It does have 24 filings with one regulator, so it is registered, just not with the two strong registers buyers usually screen on.
Is Elite Laboratories FDA-registered?
One site operated by Elite Laboratories 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 Elite Laboratories's last inspection go?
The most recent inspection on record closed on 1 August 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file, of which 1 closed as OAI.
Where does Elite Laboratories manufacture?
1 registered site is on record, in United States (Northvale). Every site is listed on this page with the register it came from.
Which regulators recognise Elite Laboratories'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

  • 7 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 1 August 2025.

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Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

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