Suppliers / Woodstock Sterile Solutions

Woodstock Sterile Solutions

United States 177 employees Updated 9 July 2026

Woodstock Sterile Solutions is a finished-dose manufacturer based in United States. It appears in 2 regulatory filings across 2 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC) and DIGEMAPS (DO). Its GMP standing is certified by ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 13 October 2022 as NAI.

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

  • 13 October 2022 NAI US FDA
  • 3 July 2018 NAI US FDA
  • 16 November 2015 VAI US FDA
  • 22 August 2014 VAI US FDA
  • 16 May 2013 NAI US FDA
  • 7 May 2012 VAI US FDA
  • 20 April 2011 NAI US FDA
  • 10 November 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
WOODSTOCK, United States Not on file
Woodstock, United States 1419377

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 1 None
DIGEMAPS (DO) 1 None
ANVISA (Brazil) None 1

Questions about Woodstock Sterile Solutions

Does Woodstock Sterile Solutions hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Woodstock Sterile Solutions. It does have 2 filings with 2 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Woodstock Sterile Solutions FDA-registered?
One site operated by Woodstock Sterile Solutions 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 Woodstock Sterile Solutions's last inspection go?
The most recent inspection on record closed on 13 October 2022 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file.
Where does Woodstock Sterile Solutions manufacture?
2 registered sites are on record, in United States (Woodstock and Woodstock). Every site is listed on this page with the register it came from.
Which regulators recognise Woodstock Sterile Solutions's GMP?
Current GMP certificates are on record from 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 NAI, on 13 October 2022.

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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