FDA Inspection 1140698 — Sircle Laboratories, L.L.C.
The FDA completed an inspection of Sircle Laboratories, L.L.C. on April 26, 2021 in Madison, MS. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 26, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Madison, MS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1079 | 21 CFR 211.22(a) | Contract drug products--lack of responsibility |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |