FDA Inspection 1074295 — Siddha Flower Essences, LLC.
The FDA completed an inspection of Siddha Flower Essences, LLC. on December 12, 2018 in Oxnard, CA. 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
- December 12, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Oxnard, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 1843 | 21 CFR 211.84(d)(2) | Component written specification |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |