FDA Inspection 1211725 — Biocalth International, Inc.
The FDA completed an inspection of Biocalth International, Inc. on August 8, 2023 in La Verne, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 8, 2023
- Fiscal Year
- 2023
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- La Verne, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15597 | 21 CFR 111.160(c)(3) | Labels - quality control; approve, release |
| 15759 | 21 CFR 111.205(b)(2) | Master manufacturing record - controls, procedures |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15862 | 21 CFR 111.75(a)(2) | Appropriate tests, examinations; certificate of analysis |
| 15944 | 21 CFR 111.105(i) | QC - required operations master manufacturing/batch records |