1045431
Indiana Botanic Gardens, Inc — FEI 1811575
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 23, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hobart, IN (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 15404 | 21 CFR 111.12(c) | Personnel - education, training, experience |
| 15642 | 21 CFR 111.455(a) | Hold - temperature, humidity, light |
| 16017 | 21 CFR 111.140(b)(3) | Records - material review, disposition documentation |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 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 |