1071015
Med Shop Total Care Inc. — FEI 3002835459
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 1, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Longview, TX (United States)
Citations
| ID | CFR | Description |
|---|
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 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 |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |