FDA Inspection 945069 — PharMEDium Services, LLC
The FDA completed an inspection of PharMEDium Services, LLC on September 24, 2015 in Sugar Land, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 24, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sugar Land, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 18008 | FDCA 503B(a)(10) | Drug product label, outsourcer facility |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |
| 2020 | 21 CFR 211.188(b)(8) | Labeling Control Records and Label Copies |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |