FDA Inspection 982567 — SCS Direct Inc.
The FDA completed an inspection of SCS Direct Inc. on August 23, 2016 in Trumbull, CT. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 23, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Trumbull, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 2044 | 21 CFR 211.196 | Distribution Record Requirements |
| 4338 | 21 CFR 211.150(b) | Recall facilitation |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |