FDA Inspection 876782 — Health Specialty
The FDA completed an inspection of Health Specialty on April 25, 2014 in Santa Fe Springs, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 25, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Santa Fe Springs, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2197 | 21 CFR 211.186(b)(2) | Active Ingredient Name and Weight |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 4400 | 21 CFR 211.186(b)(8) | Description of containers, labels, et. al. |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |