1024482
Al.Ma Cosmetics — FEI 3010164134
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 8, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Crema (Italy)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 2003 | 21 CFR 211.184(c) | Individual inventory record |
| 2011 | 21 CFR 211.188(a) | Accurate reproduction |
| 2020 | 21 CFR 211.188(b)(8) | Labeling Control Records and Label Copies |
| 2024 | 21 CFR 211.188(b)(12) | Documentation of Batch Investigations |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3560 | 21 CFR 211.56(a) | Trash and organic waste timely disposal |
| 4373 | 21 CFR 211.188(b)(7) | Actual yield, % of theoretical yield |