Company
United StatesWater-Jel Technologies, LLC, Huntersville, NC – FDA Inspections
Inspection records and compliance data for Water-Jel Technologies, LLC in Huntersville, North Carolina. 10 FDA inspections on record (2 OAI), 5 Form 483s, last inspected September 20, 2024.
Company Profile
This profile covers Water-Jel Technologies, LLC based in Huntersville, North Carolina, United States.
FDA Inspection History
- FDA inspections
- 10
- OAI
- 2
- VAI
- 7
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 5
- Warning letters
- 0
First inspected March 26, 2010. Last inspected September 20, 2024.
Most cited issue areas
- Investigations of discrepancies, failures2 inspections
- Storage under appropriate conditions2 inspections
- Absence of Written Procedures1 inspection
FDA inspections (10)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 20, 2024 | OAI | Human Drugs · Drug Quality Assurance | 1249649 |
| August 18, 2021 | VAI | Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance | 1149069 |
| August 15, 2019 | OAI | Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance | 1099591 |
| October 24, 2018 | Not classified | Medical Devices & Rad Health | 1096394 |
| September 20, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1026705 |
| November 4, 2016 | VAI | Human Drugs · Drug Quality Assurance | 992245 |
| October 10, 2014 | VAI | Human Drugs · Drug Quality Assurance | 900118 |
| September 19, 2012 | VAI | Human Drugs · Drug Quality Assurance | 799336 |
| September 22, 2010 | VAI | Human Drugs · Drug Quality Assurance | 681878 |
| March 26, 2010 | VAI | Human Drugs · Drug Quality Assurance | 653985 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Water-Jel Technologies, LLC
FEI Number
1219592
Address
13359 Reese Blvd East, Huntersville, North Carolina 28078, United States
Country
United States
ID: 70ca8046-5140-4a07-a284-c14ea4d187e8