992252
Star Health & Beauty LLC — FEI 3009275897
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 26, 2016
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Madison, GA (United States)
Citations
| ID | CFR | Description |
|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |