FDA Inspection
Spa De Soleil, Inc.Spa De Soleil, Inc. – FDA Inspection, Jan 26, 2026
Record Details
This FDA Inspection record concerns Spa De Soleil, Inc., with an inspection on January 26, 2026, issued by the Los Angeles District Office, covering human drugs.
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ID · 358c41aa-5922-4310-ac00-ab62ad15b140
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1300358
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.84(d)(2)Component identification test
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Other FDA inspections of Spa De Soleil, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 17, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 23, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 24, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 5, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Spa De Soleil, Inc.
- FDA Inspection 1149942 - 2021-09-17
- FDA Inspection 1016442 - 2017-06-23
- FDA Inspection 711706 - 2011-02-24
- FDA Inspection 651613 - 2010-03-05
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