Woodstock Sterile Solutions, Inc.
Form 483 issued July 3, 2018 · Woodstock, Illinois
- Inspection
- Jun 13 – Jul 3, 2018
- Investigators
- Brittani N. Franklin· Christopher D. Leach
- Observations
- 1
- Pages
- 3
- FEI number
- 1419377
In short: On July 3, 2018, FDA issued a Form 483 with 1 observation to Woodstock Sterile Solutions, Inc. in Woodstock, Illinois (FEI 1419377) after an inspection that ran Jun 13 – Jul 3, 2018. The investigators were Brittani N. Franklin and Christopher D. Leach. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.86 (acceptance status).
At a glance
1 of 1 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.86 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The acceptance status of…
This inspection in context
Brittani N. Franklin
5 documents · 2016–2019
Cites 803.17 (what are the requirements for developing, maintaining, and implementing written mdr procedures that apply to me?) 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 820.86
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Woodstock Sterile Solutions, Inc.?
FDA listed 1 observation on this Form 483, mostly about production & process controls. The most-cited regulation is 21 CFR 820.86 (acceptance status). The opening words of each observation are shown on this page.
Who inspected Woodstock Sterile Solutions, Inc.?
Brittani N. Franklin and Christopher D. Leach are named on this Form 483, for the inspection of Jun 13 – Jul 3, 2018. Each investigator has a profile showing what they cite most.
When was Woodstock Sterile Solutions, Inc. inspected by FDA?
The inspection ran Jun 13 – Jul 3, 2018, and the Form 483 is dated July 3, 2018.
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.