FDA Inspection 1140223 — Pronatura Inc.
The FDA completed an inspection of Pronatura Inc. on April 13, 2021 in Rolling Meadows, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 13, 2021
- Fiscal Year
- 2021
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Rolling Meadows, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15796 | 21 CFR 111.430(b) | Records - packaging, labeling operations |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15841 | 21 CFR 111.70(f) | Specifications - product received for packaging, labeling |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |