Fenwal International, Inc.
FDA inspection history across 2 sites, 2014 to 2022
- 5
- Form 483s
- 2
- Close-outs
Every document, by year
- Form 483
- Close-out
2014: one close-out letter; 2015: one Form 483; 2017: one Form 483; 2019: one Form 483; 2020: one close-out letter; 2021: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–22Five Form 483s and two close-out letters, at Lake Zurich, Illinois and Maricao, Puerto Rico.
- 2022The longest 483 on file: 9 observations over 8 pages at Maricao, Puerto Rico.
Cited most
Across all Fenwal International observations on file
- 21 CFR 211.113(b)Control of microbiological contamination3
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 211.100(a)Written procedures; deviations2
- 21 CFR 211.192Production record review2
- 21 CFR 211.198(a)Complaint files2
The complete Fenwal International file.
All 7 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Maricao, Puerto Rico
Five Form 483s · 2015 to 2022 · 26 observations
Latest: Form 483, Sep 24, 2022 →Lake Zurich, Illinois
One close-out letter · 2014
Latest: Close-out, Apr 23, 2014 →
Also: one document not tied to a site.
Documents
7 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-09-24 | 483 Form 483 | Maricao, Puerto Rico | 9 | $99 |
| 2021-09-24 | 483 Form 483 | Maricao, Puerto Rico | 4 | $99 |
| 2020-06-14 | Close-out Close-out letter | — | — | $99 |
| 2019-09-26 | 483 Form 483 | Maricao, Puerto Rico | 6 | $99 |
| 2017-08-22 | 483 Form 483 | Maricao, Puerto Rico | 4 | $99 |
| 2015-03-25 | 483 Form 483 | Maricao, Puerto Rico | 3 | $99 |
| 2014-04-23 | Close-out Close-out letter | Lake Zurich, Illinois | — | $99 |
Investigators on these documents
Laura E. Garcia (3)Cassandra L. Abellard (1)Jose A. Cruz-Gonzalez (1)Laurimer Kuilan-Torres (1)Nimmy Mathews (1)Randy L. Clarida (1)Annette Melendez (1)Scott Ballard (1)
FEI number 2627511 · most recent document Sep 24, 2022
About Fenwal International, Inc.
How many FDA Form 483s has Fenwal International, Inc. received?
FDA Intel has 5 Form 483s on file for Fenwal International, Inc.; the most recent is dated Sep 24, 2022.
When was Fenwal International, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Fenwal International, Inc. is a Form 483 dated Sep 24, 2022, for the site in Maricao, Puerto Rico.
What did FDA cite at Fenwal International, Inc.?
The regulations cited most in the observations on file for Fenwal International, Inc. are 21 CFR 211.113(b) (Control of microbiological contamination), 3 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 3 times; 21 CFR 211.100(a) (Written procedures; deviations), 2 times.