FDA Inspection 1037642 — Health Genesis Corporation
The FDA completed an inspection of Health Genesis Corporation on January 12, 2018 in Davie, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 12, 2018
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Davie, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15563 | 21 CFR 111.260(l)(1)(i) | Batch record - quality control review; monitoring |
| 15610 | 21 CFR 111.165(d)(1) | Product received - identify |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15771 | 21 CFR 111.415(h) | Obsolete labels, packaging - dispose |
| 15963 | 21 CFR 111.113(b)(2) | Quality control - reject; specification not met |