Company
United StatesPublic company, OTC: KLYGKelyniam Global, Inc. (OTC: KLYG), Collinsville, CT – FDA Inspections
Inspection records and compliance data for Kelyniam Global, Inc. in Collinsville, Connecticut. 6 FDA inspections on record (1 OAI), 3 Form 483s, 1 warning letter, last inspected August 23, 2024. Publicly traded as OTC: KLYG.
Company Profile
This profile covers Kelyniam Global, Inc. based in Collinsville, Connecticut, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 1
- VAI
- 4
- NAI
- 1
- Form 483s
- 3
- Warning letters
- 1
First inspected April 17, 2013. Last inspected August 23, 2024.
Most cited issue areas
- Lack of or inadequate process validation5 inspections
- Environmental control Lack of or inadequate procedures3 inspections
- DHR content2 inspections
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 23, 2024 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1230547 |
| July 22, 2021 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1146978 |
| August 15, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1100191 |
| September 25, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1066747 |
| May 30, 2017 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1011997 |
| April 17, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 831319 |
FDA documents
Warning Letters (1)
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Company Information
Name
Kelyniam Global, Inc.
Stock ticker
KLYG
Exchange
OTC
Price as of
November 13, 2026
FEI Number
3009424796
Address
97 River Rd, Collinsville, Connecticut 06019, United States
Country
United States
ID: 447b1f6a-d649-4aa2-9115-afbe99879688