Suppliers / Pure Source

Pure Source

United States 39 employees Updated 9 July 2026

Pure Source is a finished-dose manufacturer based in United States. It appears in 8 regulatory filings across 3 regulators, without an active US DMF or CEP on file. Its filings concentrate with JFDA (JO), DIGEMAPS (DO) and INVIMA (CO). Its most recent recorded inspection, by US FDA, closed on 14 August 2019 as VAI.

0
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
8
filings across 3 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 14 August 2019 VAI US FDA
  • 1 March 2018 OAI US FDA
  • 24 February 2014 VAI US FDA
  • 22 September 2011 VAI US FDA
  • 29 September 2009 VAI US FDA

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

Registered plants

Site FDA FEI
Doral, United States 3002754162

Filings and GMP by regulator

Regulator Filings GMP certificates
JFDA (JO) 4 None
DIGEMAPS (DO) 3 None
INVIMA (CO) 1 None

Questions about Pure Source

Does Pure Source hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Pure Source. It does have 8 filings with 3 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Pure Source FDA-registered?
One site operated by Pure Source 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 Pure Source's last inspection go?
The most recent inspection on record closed on 14 August 2019 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file, of which 1 closed as OAI.
Where does Pure Source manufacture?
1 registered site is on record, in United States (Doral). Every site is listed on this page with the register it came from.
Where does Pure Source file?
Filings are on record with JFDA (JO), DIGEMAPS (DO) and INVIMA (CO), 8 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 14 August 2019.

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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