FDA Inspection
Clinical Resolution Laboratory Inc.Clinical Resolution Laboratory Inc. – FDA Inspection, May 15, 2018
Record Details
This FDA Inspection record concerns Clinical Resolution Laboratory Inc., with an inspection on May 15, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 7cb02948-d61e-417a-90c3-d092b785638d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1051991
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.166(b)Accelerated stability studies
- 21 CFR 211.198(b)Maintenance of Complaint File
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.25(b)Supervisor Training/Education/Experience
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.84(d)(2)Component identification test
- 21 CFR 211.100(a)Approval and review of procedures
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.84(d)(2)Establish reliability of supplier's C of A
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Other FDA inspections of Clinical Resolution Laboratory Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 16, 2025 | Not classified | Los Angeles District Office | Drug Quality Assurance |
| August 12, 2024 | VAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| September 29, 2023 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Clinical Resolution Laboratory Inc.
- FDA Inspection 1258727 - 2025-01-16
- FDA Inspection 1248213 - 2024-08-12
- FDA Inspection 1219464 - 2023-09-29
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