Suppliers / Winder Laboratories

Winder Laboratories

United States Updated 9 July 2026

Winder Laboratories is a finished-dose manufacturer based in United States. It appears in 12 regulatory filings across 1 regulator, without an active US DMF or CEP on file. Its most recent recorded inspection, by US FDA, closed on 5 August 2025 as OAI.

0
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
12
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

  • 5 August 2025 OAI US FDA
  • 5 February 2025 NAI US FDA
  • 13 March 2020 VAI US FDA
  • 18 July 2018 OAI US FDA
  • 9 June 2017 NAI US FDA
  • 25 February 2016 VAI US FDA
  • 3 December 2015 VAI US FDA
  • 10 February 2009 NAI US FDA

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

Registered plants

Site FDA FEI
WINDER, United States 3008694072

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 12 None

Questions about Winder Laboratories

Does Winder Laboratories hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Winder Laboratories. It does have 12 filings with one regulator, so it is registered, just not with the two strong registers buyers usually screen on.
Is Winder Laboratories FDA-registered?
One site operated by Winder 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 Winder Laboratories's last inspection go?
The most recent inspection on record closed on 5 August 2025 as OAI (Official Action Indicated, the worst classification: objectionable conditions were found and regulatory action was warranted). 8 inspections are on file, of which 2 closed as OAI.
Where does Winder Laboratories manufacture?
1 registered site is on record, in United States (Winder). Every site is listed on this page with the register it came from.
Where does Winder Laboratories file?
Filings are on record with US FDA, 12 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 OAI, on 5 August 2025.

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Sources on this page

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