Woodstock Sterile Solutions, Inc.
Form 483 issued March 3, 2022 · Woodstock, Illinois
- Inspection
- Feb 28 – Mar 3, 2022
- Observations
- 2
- Pages
- 3
- FEI number
- 1419377
In short: On March 3, 2022, FDA issued a Form 483 with 2 observations to Woodstock Sterile Solutions, Inc. in Woodstock, Illinois (FEI 1419377) after an inspection that ran Feb 28 – Mar 3, 2022. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.194 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to adequately investigate…
- 02
No contemporaneous verification of the bioburden…
This inspection in context
Questions about this 483
What did FDA find at Woodstock Sterile Solutions, Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was Woodstock Sterile Solutions, Inc. inspected by FDA?
The inspection ran Feb 28 – Mar 3, 2022, and the Form 483 is dated March 3, 2022.
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.