FDA Inspection 1179727 — Sircle Laboratories, L.L.C.
The FDA completed an inspection of Sircle Laboratories, L.L.C. on September 16, 2022 in Madison, MS. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 16, 2022
- Fiscal Year
- 2022
- 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 |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |