FDA Inspection 1210957 — Krakatoa Inc (FL)
The FDA completed an inspection of Krakatoa Inc (FL) on July 19, 2023 in Palm Bay, FL. 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
- July 19, 2023
- Fiscal Year
- 2023
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Palm Bay, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15698 | 21 CFR 111.320(a) | Examination, testing; appropriate |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15774 | 21 CFR 111.415(f)(1) | Batch-lot,control number packaged, labeled dietary supplemen |
| 15841 | 21 CFR 111.70(f) | Specifications - product received for packaging, labeling |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |