FDA Inspection 1195175 — Cornerstone Laboratories LLC
The FDA completed an inspection of Cornerstone Laboratories LLC on Jan 19, 2023 in Memphis, TN. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jan 19, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Memphis, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |