FDA Inspection 1119831 — Let's Talk Health, Inc.
The FDA completed an inspection of Let's Talk Health, Inc. on February 27, 2020 in Chula Vista, CA. 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
- February 27, 2020
- Fiscal Year
- 2020
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Chula Vista, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15381 | 21 CFR 111.8 | Written procedures - hygienic practices |
| 15453 | 21 CFR 111.16 | Written procedures - cleaning |
| 15573 | 21 CFR 111.153 | Written procedures - product received; packaging, labeling |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15790 | 21 CFR 111.403 | Written procedures - labeling operations |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15928 | 21 CFR 111.103 | Written procedure quality control operations material review |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |