1018509
Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy — FEI 3011123993
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 20, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Fort Myers, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 1174 | 21 CFR 211.42(b) | Product flow through building is inadequate |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1849 | 21 CFR 211.84(d)(6) | Objectionable microbiological contamination |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1933 | 21 CFR 211.167(a) | Sterility/pyrogens - test methods written, followed |