FDA Inspection 1083116 — Sircle Laboratories, L.L.C.
The FDA completed an inspection of Sircle Laboratories, L.L.C. on Mar 19, 2019 in Madison, MS. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Mar 19, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Madison, MS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1079 | 21 CFR 211.22(a) | Contract drug products--lack of responsibility |
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 4386 | 21 CFR 211.198(b) | Written complaint record to be maintained at facility |