FDA Inspection 960009 — Concord, Inc. dba Carlton's Dunwoody Pharmacy
The FDA completed an inspection of Concord, Inc. dba Carlton's Dunwoody Pharmacy on January 13, 2016 in Dunwoody, GA. 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
- January 13, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dunwoody, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |