Suppliers / Rafa Laboratories

Rafa Laboratories

Israel Updated 9 July 2026

Rafa Laboratories is a finished-dose manufacturer based in Israel. It appears in 3 regulatory filings across 2 regulators, without an active US DMF or CEP on file. Its filings concentrate with US FDA and MINSA (CR). Its GMP standing is certified by EMA and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 25 November 2019 as VAI.

0
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
3
filings across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
3 of 3 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 25 November 2019 VAI US FDA
  • 13 November 2017 VAI US FDA
  • 29 September 2016 VAI US FDA

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

Registered plants

Site FDA FEI
JERUSALEM, Israel Not on file
Israel, Israel 3004437307

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 2 None
MINSA (CR) 1 None
EMA None 6
ANVISA (Brazil) None 1

Questions about Rafa Laboratories

Does Rafa Laboratories hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Rafa Laboratories. It does have 3 filings with 2 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Rafa Laboratories FDA-registered?
One site operated by Rafa 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 Rafa Laboratories's last inspection go?
The most recent inspection on record closed on 25 November 2019 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.
Where does Rafa Laboratories manufacture?
2 registered sites are on record, in Israel (Jerusalem and Israel). Every site is listed on this page with the register it came from.
Which regulators recognise Rafa Laboratories's GMP?
Current GMP certificates are on record from EMA and ANVISA (Brazil). 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 VAI, on 25 November 2019.

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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