1092976
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy — FEI 3015235235
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 14, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Mesa, AZ (United States)
Citations
| ID | CFR | Description |
|---|
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 1433 | 21 CFR 211.42(c)(10)(iii) | Air Supply |
| 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 |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4366 | 21 CFR 211.188(a) | Accurate reproduction included |
| 4576 | 21 CFR 211.192 | No written record of investigation |