FDA Inspection 1307734 — Custom Analytics LLC
The FDA completed an inspection of Custom Analytics LLC on March 12, 2026 in Dalzell, SC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 12, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dalzell, SC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |