FDA Inspection 998846 — Select Consumer Group, LLC
The FDA completed an inspection of Select Consumer Group, LLC on January 20, 2017 in Carrollton, TX. 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
- January 20, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Carrollton, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 1957 | 21 CFR 211.180(e)(2) | Review of problem drugs |
| 4387 | 21 CFR 211.198(a) | Reporting of adverse drug experience to FDA |