FDA Inspection
Spa De Soleil, Inc.Spa De Soleil, Inc. – FDA Inspection, Jun 23, 2017
Record Details
This FDA Inspection record concerns Spa De Soleil, Inc., with an inspection on June 23, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · ffdaff7a-7367-44f8-bd6a-099ba5bf68f7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1016442
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.165(c)Sampling and testing plans not described
- 21 CFR 211.186(a)Signature and checking of records -- 2 persons
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.122(a)Written procedures describing in detail
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.182Written records kept in individual logs
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 |
| September 17, 2021 | 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 1149942 - 2021-09-17
- FDA Inspection 711706 - 2011-02-24
- FDA Inspection 651613 - 2010-03-05
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.