FDA Inspection 1089620 — Nature's Innovation, Inc.
The FDA completed an inspection of Nature's Innovation, Inc. on May 14, 2019 in Buford, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 14, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Buford, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2044 | 21 CFR 211.196 | Distribution Record Requirements |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4373 | 21 CFR 211.188(b)(7) | Actual yield, % of theoretical yield |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |