FDA Inspection 581661 — Custom Analytics LLC
The FDA completed an inspection of Custom Analytics LLC on May 5, 2009 in Dalzell, SC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 5, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dalzell, SC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 2034 | 21 CFR 211.194(d) | Laboratory equipment calibration records |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |