Hydrox Laboratories
FDA inspection history in Elgin, Illinois, 2016 to 2021
- 2
- Form 483s
Every document, by year
- Form 483
2016: one Form 483; 2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One Form 483, at Elgin, Illinois.
- 2021One Form 483, at Elgin, Illinois.
- 2021The longest 483 on file: 9 observations over 11 pages at Elgin, Illinois.
Cited most
Across all Hydrox Laboratories observations on file
- 21 CFR 211.67Equipment cleaning and maintenance4
- 21 CFR 211.192Production record review3
- 21 CFR 211.165Testing and release for distribution2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.105Equipment identification1
The complete Hydrox Laboratories file.
All 2 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
Elgin, Illinois
Two Form 483s · 2016 to 2021 · 16 observations
Latest: Form 483, Jun 24, 2021 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-06-24 | 483 Form 483 | Elgin, Illinois | 9 | $99 |
| 2016-06-09 | 483 Form 483 | Elgin, Illinois | 7 | $99 |
Investigators on these documents
Brian D. Nicholson (1)Goran Periz (1)John Misock (1)Kevin P. Regan (1)
FEI number 1419821 · most recent document Jun 24, 2021
About Hydrox Laboratories
How many FDA Form 483s has Hydrox Laboratories received?
FDA Intel has 2 Form 483s on file for Hydrox Laboratories; the most recent is dated Jun 24, 2021.
When was Hydrox Laboratories last inspected by FDA?
The most recent FDA inspection document on file for Hydrox Laboratories is a Form 483 dated Jun 24, 2021, for the site in Elgin, Illinois.
What did FDA cite at Hydrox Laboratories?
The regulations cited most in the observations on file for Hydrox Laboratories are 21 CFR 211.67 (Equipment cleaning and maintenance), 4 times; 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.165 (Testing and release for distribution), 2 times.