Woodstock Sterile Solutions, Inc.
Form 483 issued May 28, 2021 · Woodstock, Illinois
- Inspection
- May 24 – May 28, 2021
- Investigator
- Alea E. Melendez
- Observations
- 7
- Pages
- 6
- FEI number
- 1419377
In short: On May 28, 2021, FDA issued a Form 483 with 7 observations to Woodstock Sterile Solutions, Inc. in Woodstock, Illinois (FEI 1419377) after an inspection that ran May 24 – May 28, 2021. The investigator was Alea E. Melendez. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are not established to monitor the output and validate the…
- 02
Appropriate controls over computer or related systems are not exercised to assure that all changes in…
- 03
Equipment used in the manufacturing, processing, and holding of drug products are not properly qualified according…
- 04
Execution of process controls and procedures are not always documented at…
This inspection in context
Alea E. Melendez
1 document · 2021
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 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Woodstock Sterile Solutions, Inc.?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and materials. 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.?
Alea E. Melendez is named on this Form 483, for the inspection of May 24 – May 28, 2021. Each investigator has a profile showing what they cite most.
When was Woodstock Sterile Solutions, Inc. inspected by FDA?
The inspection ran May 24 – May 28, 2021, and the Form 483 is dated May 28, 2021.
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.