FDA Inspection
Water-Jel Technologies, LLCWater-Jel Technologies, LLC – FDA Inspection, Aug 15, 2019
Record Details
This FDA Inspection record concerns Water-Jel Technologies, LLC, with an inspection on August 15, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 47c7a28e-b56f-4dd8-b001-eaed45fb43a7
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1099591
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 211.84(d)(3)Establish reliability of supplier"s C of A
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 820.184DHR content
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Other FDA inspections of Water-Jel Technologies, LLC
9| Date | Classification | Office | Project area |
|---|---|---|---|
| September 20, 2024 | OAI | Atlanta District Office | Drug Quality Assurance |
| August 18, 2021 | VAI | 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 1249649 - 2024-09-20
- FDA Inspection 1149069 - 2021-08-18
- FDA Inspection 1096394 - 2018-10-24
- FDA Inspection 1026705 - 2017-09-20
- FDA Inspection 992245 - 2016-11-04
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