FDA Inspection 1321748 — Inspec Solutions LLC
The FDA completed an inspection of Inspec Solutions LLC on Jun 12, 2026 in Holly Hill, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 12, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Holly Hill, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |