FDA Inspection 1099497 — Eden's Answers Inc
The FDA completed an inspection of Eden's Answers Inc on August 14, 2019 in Holmesville, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 14, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Holmesville, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1223 | 21 CFR 211.67(b)(5) | Cleaning SOPs/equipment protection |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |