FDA Inspection 968453 — Food for Health International, LLC
The FDA completed an inspection of Food for Health International, LLC on March 31, 2016 in Salt Lake City, UT. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 14 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 31, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Salt Lake City, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15447 | 21 CFR 111.15(c)(3) | Cleaning compounds and toxic materials - holding |
| 15529 | 21 CFR 111.30(e) | Equipment - controls, intended use |
| 15567 | 21 CFR 111.260(l)(4) | Batch record - approved, released, rejected |
| 15743 | 21 CFR 111.210(h)(3) | Master manufacturing record - specific actions; quality |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15796 | 21 CFR 111.430(b) | Records - packaging, labeling operations |
| 15828 | 21 CFR 111.70(a) | Specifications - manufacturing process |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15867 | 21 CFR 111.75(b)(1) | Specifications met, in-process - quality finished batch |
| 15871 | 21 CFR 111.75(c)(2) | Specifications met - test, examinations; compliance |
| 15885 | 21 CFR 111.77(a) | Specifications not met - reject, quality control |
| 15995 | 21 CFR 111.127(d) | Quality control operations - packaged, labeled; specifications |