FDA Inspection 1270598 — Sklar BOV Solutions, Inc
The FDA completed an inspection of Sklar BOV Solutions, Inc on May 23, 2025 in Statesville, NC. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 23, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Statesville, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |