FDA Inspection
Redi-2-Paq Home Products LLCRedi-2-Paq Home Products LLC – FDA Inspection, Nov 4, 2019
Record Details
This FDA Inspection record concerns Redi-2-Paq Home Products LLC, with an inspection on November 4, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Redi-2-Paq Home Products LLC
- Inspection Date
- November 4, 2019
- Product Type
- Drugs
View Company Profile
ID · f4034c7b-4a22-440c-97fc-8f62134f2c60
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1110262
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.84(d)(2)Component written specification
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Redi-2-Paq Home Products LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 16, 2026 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
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