776471
Skin Biology Inc — FEI 1000208498
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 30, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Bellevue, WA (United States)
Citations
| ID | CFR | Description |
|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3557 | 21 CFR 211.52 | Washing and toilet facilities are deficient |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |