FDA Inspection 937270 — PharMEDium Services LLC
The FDA completed an inspection of PharMEDium Services LLC on July 13, 2015 in Dayton, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 13, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dayton, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 1174 | 21 CFR 211.42(b) | Product flow through building is inadequate |
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 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 |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |