FDA Inspection
Kleen Concepts, LLCKleen Concepts, LLC – FDA Inspection, Oct 30, 2018
Record Details
This FDA Inspection record concerns Kleen Concepts, LLC, with an inspection on October 30, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 52da1ac5-ec84-4514-a85d-c487e70861b9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1070425
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.160(b)(1)Incoming lots - conformance to written specs-
- 21 CFR 211.170(b)Reserve samples identified, representative, stored
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Kleen Concepts, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 16, 2025 | VAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
Other documents for Kleen Concepts, LLC
- FDA Inspection 1269798 - 2025-04-16
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