Water-Jel Technologies, LLC
FDA inspection history in Huntersville, North Carolina, 2019
- 1
- Form 483
Every document, by year
- Form 483
2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Huntersville, North Carolina.
Cited most
Across all Water-Jel Technologies observations on file
- 21 CFR 211.188(b)Batch production and control records1
- 21 CFR 211.192Production record review1
- 21 CFR 211.84(d)(3)Testing and approval or rejection of components, drug product containers, and closures1
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.181Device master record1
The complete Water-Jel Technologies file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Huntersville, North Carolina
One Form 483 · 2019 · 11 observations
Latest: Form 483, Aug 15, 2019 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-08-15 | 483 Form 483 | Huntersville, North Carolina | 11 | $99 |
Investigators on these documents
FEI number 1219592 · most recent document Aug 15, 2019
About Water-Jel Technologies, LLC
How many FDA Form 483s has Water-Jel Technologies, LLC received?
FDA Intel has 1 Form 483 on file for Water-Jel Technologies, LLC; the most recent is dated Aug 15, 2019.
When was Water-Jel Technologies, LLC last inspected by FDA?
The most recent FDA inspection document on file for Water-Jel Technologies, LLC is a Form 483 dated Aug 15, 2019, for the site in Huntersville, North Carolina.
What did FDA cite at Water-Jel Technologies, LLC?
The regulations cited most in the observations on file for Water-Jel Technologies, LLC are 21 CFR 211.188(b) (Batch production and control records), 1 time; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.84(d)(3) (Testing and approval or rejection of components, drug product containers, and closures), 1 time.