FDA Inspection 1014452 — Almil Nutritional Products Inc
The FDA completed an inspection of Almil Nutritional Products Inc on June 15, 2017 in Brea, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 15, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Brea, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1496 | 21 CFR 211.122(a) | Sampling/testing of labeling/packaging materials |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4351 | 21 CFR 211.160(b)(3) | Drug products - samples representative, identified properly |