FDA Inspection 770191 — A-S Medication Solutions LLC
The FDA completed an inspection of A-S Medication Solutions LLC on March 2, 2012 in Libertyville, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 2, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Libertyville, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1411 | 21 CFR 211.105(b) | Distinctive ID or code not recorded in batch record |
| 1506 | 21 CFR 211.122(e) | Destruction of obsolete labeling |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2569 | 21 CFR 211.198(b) | Maintenance of Complaint File |
| 2621 | 21 CFR 211.198(b)(3) | Reason for Not Conducting Complaint Investigation |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4382 | 21 CFR 211.198(b)(2) | Written record of complaint to include findings, follow-up |