FDA Inspection 1051103 — Heara Inc
The FDA completed an inspection of Heara Inc on May 8, 2018 in Miami, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 14 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 8, 2018
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1007 | 21 CFR 110.10(b)(9) | Precautions against contamination--micro, foreign substances |
| 1130 | 21 CFR 110.40(a) | Food-contact - withstand food & cleaning cmpds. |
| 1292 | 21 CFR 110.20(b)(1) | Sufficient space |
| 1306 | 21 CFR 110.20(b)(7) | Screening |
| 1402 | 21 CFR 110.10(b)(4) | Unsecured jewelry |
| 1424 | 21 CFR 110.20(b)(4) | Drip and condensate |
| 1552 | 21 CFR 110.35(a) | Buildings/sanitary |
| 1560 | 21 CFR 110.35(c) | Lack of effective pest exclusion |
| 1562 | 21 CFR 110.35(d) | Failure to clean - general |
| 1566 | 21 CFR 110.35(d)(4) | Single-service articles |
| 1581 | 21 CFR 110.37(e) | Running water at suitable temperature |
| 1596 | 21 CFR 110.37(b)(2) | Convey sewage |
| 2386 | 21 CFR 110.80(a)(1) | Storage |
| 990 | 21 CFR 110.10(b)(3) | Not washed/sanitized when appropriate |