Kelyniam Global, Inc.
FDA inspection history across 2 sites, 2017 to 2024
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2017: one warning letter; 2019: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–19One warning letter and one Form 483, at Canton, Connecticut and Collinsville, Connecticut.
- 2024One Form 483, at Collinsville, Connecticut.
- 2024The longest 483 on file: 5 observations over 7 pages at Collinsville, Connecticut.
Cited most
Across all Kelyniam Global observations on file
- 21 CFR 820.184Device history record1
- 21 CFR 820.22Quality audit1
- 21 CFR 820.25(b)Personnel1
- 21 CFR 820.50Purchasing controls1
- 21 CFR 820.70(c)Production and process controls1
The complete Kelyniam Global file.
All 3 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
Collinsville, Connecticut
Two Form 483s · 2019 to 2024 · 6 observations
Latest: Form 483, Aug 23, 2024 →Canton, Connecticut
One warning letter · 2017
Latest: Warning letter, Oct 5, 2017 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-08-23 | 483 Form 483 | Collinsville, Connecticut | 5 | $99 |
| 2019-08-15 | 483 Form 483 | Collinsville, Connecticut | 1 | $99 |
| 2017-10-05 | Warning letter Warning letter | Canton, Connecticut | — | $99 |
Investigators on these documents
FEI number 3009424796 · most recent document Aug 23, 2024
About Kelyniam Global, Inc.
How many FDA Form 483s has Kelyniam Global, Inc. received?
FDA Intel has 2 Form 483s on file for Kelyniam Global, Inc.; the most recent is dated Aug 23, 2024.
When was Kelyniam Global, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Kelyniam Global, Inc. is a Form 483 dated Aug 23, 2024, for the site in Collinsville, Connecticut.
What did FDA cite at Kelyniam Global, Inc.?
The regulations cited most in the observations on file for Kelyniam Global, Inc. are 21 CFR 820.184 (Device history record), 1 time; 21 CFR 820.22 (Quality audit), 1 time; 21 CFR 820.25(b) (Personnel), 1 time.
Has Kelyniam Global, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Kelyniam Global, Inc.; the most recent is dated Oct 5, 2017.