Woodstock Sterile Solutions, Inc.
Form 483 issued June 25, 2019 · Woodstock, Illinois
- Inspection
- Jun 17 – Jun 25, 2019
- Investigators
- Amy Devlin· Peng Zhou· Wayne Seifert
- Observations
- 5
- Pages
- 3
- FEI number
- 1419377
In short: On June 25, 2019, FDA issued a Form 483 with 5 observations to Woodstock Sterile Solutions, Inc. in Woodstock, Illinois (FEI 1419377) after an inspection that ran Jun 17 – Jun 25, 2019. The investigators were Amy Devlin, Peng Zhou and Wayne Seifert. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and production account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Environmental monitoring (EM) for the Suite™™ BFS fill machine…
- 02
Standard Operating Procedures (SOPs)…
- 03
The visual inspection process…
- 04
Utilities and equipment are…
This inspection in context
Amy Devlin
4 documents · 2019–2020
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Illinois.
The firmWoodstock Sterile Solutions, Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Woodstock Sterile Solutions, Inc.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Woodstock Sterile Solutions, Inc.?
Amy Devlin, Peng Zhou and Wayne Seifert are named on this Form 483, for the inspection of Jun 17 – Jun 25, 2019. Each investigator has a profile showing what they cite most.
When was Woodstock Sterile Solutions, Inc. inspected by FDA?
The inspection ran Jun 17 – Jun 25, 2019, and the Form 483 is dated June 25, 2019.
How do I get the full Form 483 for Woodstock Sterile Solutions, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.