FDA Inspection 1229644 — Puremedy Inc.
The FDA completed an inspection of Puremedy Inc. on February 12, 2024 in Westlake Village, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 12, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Westlake Village, CA (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 |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1928 | 21 CFR 211.166(c)(1) | Homeopathic drugs, assessment of stability |