FDA Inspection 1055784 — Health Care of America Enterprise Inc.
The FDA completed an inspection of Health Care of America Enterprise Inc. on June 15, 2018 in Brooklyn, NY. 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: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 15, 2018
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Brooklyn, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15606 | 21 CFR 111.165(c)(1) | Product received - quarantine; representative samples |
| 15607 | 21 CFR 111.165(c)(2) | Product received - quality control; documentation; specs |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |