FDA Inspection 628529 — A-S Medication Solutions LLC
The FDA completed an inspection of A-S Medication Solutions LLC on October 22, 2009 in Libertyville, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 22, 2009
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Libertyville, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1632 | 21 CFR 211.130(c) | Lot or control number assigned |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4341 | 21 CFR 211.142(a) | Quarantine - written procedures |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4360 | 21 CFR 211.170(b) | Reserve drug product sample quantity - all tests |