FDA Inspection 1091319 — SALUS MEDICAL LLC
The FDA completed an inspection of SALUS MEDICAL LLC on May 16, 2019 in Phoenix, AZ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 16, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Phoenix, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |