1016442
Spa De Soleil, Inc. — FEI 3003876848
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 23, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sun Valley, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1886 | 21 CFR 211.165(c) | Sampling and testing plans not described |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |