FDA Inspection
Spa De Soleil, Inc.Spa De Soleil, Inc. – FDA Inspection, Sep 17, 2021
Record Details
This FDA Inspection record concerns Spa De Soleil, Inc., with an inspection on September 17, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Spa De Soleil, Inc.
- Inspection Date
- September 17, 2021
- Product Type
- Drugs
View Company Profile
ID · 83177195-2037-4b5d-8c06-94cbf1e8dd92
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1149942
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.80(d)Status of Each Lot Identified
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.122(a)Written procedures describing in detail
- 21 CFR 211.67(b)Written procedures not established/followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Spa De Soleil, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 26, 2026 | OAI | Los Angeles District Office | 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 1300358 - 2026-01-26
- FDA Inspection 1016442 - 2017-06-23
- FDA Inspection 711706 - 2011-02-24
- FDA Inspection 651613 - 2010-03-05
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