FDA Inspection 1120521 — Absorb Health LLC
The FDA completed an inspection of Absorb Health LLC on March 12, 2020 in Supply, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 12, 2020
- Fiscal Year
- 2020
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Supply, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15404 | 21 CFR 111.12(c) | Personnel - education, training, experience |
| 15453 | 21 CFR 111.16 | Written procedures - cleaning |
| 15591 | 21 CFR 111.160(c)(1) | Labels - quarantine; samples |
| 15604 | 21 CFR 111.165(b) | Product received - visually examine invoice, guarantee, cert |
| 15606 | 21 CFR 111.165(c)(1) | Product received - quarantine; representative samples |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |
| 18140 | 21 CFR 117.20(b) | Plant construction and design |