FDA Inspection
Savings Distributors LLCSavings Distributors LLC – FDA Inspection, Aug 27, 2020
Record Details
This FDA Inspection record concerns Savings Distributors LLC, with an inspection on August 27, 2020, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Savings Distributors LLC
- Inspection Date
- August 27, 2020
- Product Type
- Drugs
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ID · f0fec936-ad75-48a0-b565-fa4ff4387937
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1128891
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.122(a)Sampling/testing of labeling/packaging materials
- 21 CFR 211.170(a)(3)Retention times for actives of OTC drugs
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(c)Defined areas of adequate size for operations
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Other FDA inspections of Savings Distributors LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 30, 2025 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| December 19, 2024 | VAI | New York District Office | Drug Quality Assurance |
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