FDA Inspection 911783 — Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy
The FDA completed an inspection of Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy on December 22, 2014 in Fort Myers, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 22, 2014
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Fort Myers, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1451 | 21 CFR 211.113(b) | Procedures for 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 |