FDA Inspection
Charlotte Products Ltd.Charlotte Products Ltd. – FDA Inspection, May 9, 2025
Record Details
This FDA Inspection record concerns Charlotte Products Ltd., with an inspection on May 9, 2025, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 345294cd-4e7f-455b-9f41-83b3fb22f505
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1269768
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of Charlotte Products Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 9, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Charlotte Products Ltd.
- FDA Inspection 1074258 - 2018-11-09
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