1012368
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 1, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Alpharetta, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4382 | 21 CFR 211.198(b)(2) | Written record of complaint to include findings, follow-up |
| 4387 | 21 CFR 211.198(a) | Reporting of adverse drug experience to FDA |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |