769908
I. Shay Cosmetics Inc — FEI 3002757783
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 21, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Harbor City, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1422 | 21 CFR 110.20(b)(4) | Floors, walls and ceilings |
| 1599 | 21 CFR 110.37(b)(5) | Backflow prevention |
| 1763 | 21 CFR 110.35(b)(1) | Safe and adequate for use |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 4406 | 21 CFR 211.194(a)(2) | Suitability of testing methods verified |