FDA Inspection
Water-Jel Technologies, LLCWater-Jel Technologies, LLC – FDA Inspection, Sep 20, 2024
Record Details
This FDA Inspection record concerns Water-Jel Technologies, LLC, with an inspection on September 20, 2024, issued by the Atlanta District Office, covering human drugs.
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ID · a06840ca-8cce-4652-bf3a-12be2120e98f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1249649
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Water-Jel Technologies, LLC
9| Date | Classification | Office | Project area |
|---|---|---|---|
| August 18, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 15, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 24, 2018 | Not classified | Atlanta District Office | |
| September 20, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 4, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Water-Jel Technologies, LLC
- FDA Inspection 1149069 - 2021-08-18
- FDA Inspection 1099591 - 2019-08-15
- FDA Inspection 1096394 - 2018-10-24
- FDA Inspection 1026705 - 2017-09-20
- FDA Inspection 992245 - 2016-11-04
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