FDA Inspection 1047678 — Pharmedium Services, LLC
The FDA completed an inspection of Pharmedium Services, LLC on April 11, 2018 in Lake Forest, IL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 11, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lake Forest, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1134 | 21 CFR 211.25(b) | Supervisor Training/Education/Experience |
| 1941 | 21 CFR 211.180(d) | Reader/Photocopy equipment not made available |
| 1958 | 21 CFR 211.180(f) | Responsible firm officials notified in writing |
| 4368 | 21 CFR 211.188(b)(12) | Investigations made into any unexplained discrepancy |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |