FDA Inspection 912826 — Health Plus Incorporated
The FDA completed an inspection of Health Plus Incorporated on February 17, 2015 in Chino, 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 17, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chino, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15388 | 21 CFR 111.10(b) | Personnel - hygienic practices |
| 15397 | 21 CFR 111.10(b)(7) | Personal belongings |
| 15672 | 21 CFR 111.315 | Laboratory control processes - reviewed, approved |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |