908025
Right Value Drug Stores LLC — FEI 3010589333
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 12, 2014
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Irving, TX (United States)
Citations
| ID | CFR | Description |
|---|
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 1174 | 21 CFR 211.42(b) | Product flow through building is inadequate |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 4320 | 21 CFR 211.84(d)(6) | Microbiological Contamination Exam |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 4377 | 21 CFR 211.188(b)(3) | Identification of each component or in-process material |