Woodstock Sterile Solutions, Inc.
FDA inspection history in Woodstock, Illinois, 2018 to 2022
- 4
- Form 483s
Every document, by year
- Form 483
2018: one Form 483; 2019: one Form 483; 2021: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–22Four Form 483s, at Woodstock, Illinois.
- 2021The longest 483 on file: 7 observations over 6 pages at Woodstock, Illinois.
Cited most
Across all Woodstock Sterile Solutions observations on file
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.192Production record review2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.165Testing and release for distribution1
The complete Woodstock Sterile Solutions file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Woodstock, Illinois
Four Form 483s · 2018 to 2022 · 15 observations
Latest: Form 483, Mar 3, 2022 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-03-03 | 483 Form 483 | Woodstock, Illinois | 2 | $99 |
| 2021-05-28 | 483 Form 483 | Woodstock, Illinois | 7 | $99 |
| 2019-06-25 | 483 Form 483 | Woodstock, Illinois | 5 | $99 |
| 2018-07-03 | 483 Form 483 | Woodstock, Illinois | 1 | $99 |
Investigators on these documents
Alea E. Melendez (1)Amy Devlin (1)Brittani N. Franklin (1)Christopher D. Leach (1)Peng Zhou (1)Wayne Seifert (1)
FEI number 1419377 · most recent document Mar 3, 2022
About Woodstock Sterile Solutions, Inc.
How many FDA Form 483s has Woodstock Sterile Solutions, Inc. received?
FDA Intel has 4 Form 483s on file for Woodstock Sterile Solutions, Inc.; the most recent is dated Mar 3, 2022.
When was Woodstock Sterile Solutions, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Woodstock Sterile Solutions, Inc. is a Form 483 dated Mar 3, 2022, for the site in Woodstock, Illinois.
What did FDA cite at Woodstock Sterile Solutions, Inc.?
The regulations cited most in the observations on file for Woodstock Sterile Solutions, Inc. are 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times.