FDA Inspection 821901 — PharMEDium Services, LLC.
The FDA completed an inspection of PharMEDium Services, LLC. on February 22, 2013 in Cleveland, MS. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 13 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 22, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cleveland, MS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1868 | 21 CFR 211.94(b) | Protection from external factors |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |
| 3548 | 21 CFR 211.46(c) | Air filtration system lacking in production area |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4316 | 21 CFR 211.84(d)(3) | Testing Containers & Closures Conformity with Specs |