FDA Inspection 1092976 — First Royal Care Co. LLC
The FDA completed an inspection of First Royal Care Co. LLC on Jun 14, 2019 in Mesa, AZ. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jun 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 |