FDA Inspection 1118190 — Health Genesis Corporation
The FDA completed an inspection of Health Genesis Corporation on Feb 18, 2020 in Davie, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 18, 2020
- Fiscal Year
- 2020
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Davie, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15720 | 21 CFR 111.370 | Rejected dietary supplements - identify, hold, control |
| 15771 | 21 CFR 111.415(h) | Obsolete labels, packaging - dispose |
| 15810 | 21 CFR 111.570(b)(2) | Record - product complaint; good manufacturing practice |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15963 | 21 CFR 111.113(b)(2) | Quality control - reject; specification not met |
| 18160 | 21 CFR 117.80(b)(8) | Raw materials - Allergen identification |