FDA Inspection 777617 — Food for Health International, LLC
The FDA completed an inspection of Food for Health International, LLC on April 18, 2012 in Salt Lake City, UT. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 18, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Salt Lake City, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15410 | 21 CFR 111.14(b)(2) | Personnel - records - training |
| 15491 | 21 CFR 111.25 | Equipment - procedures |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15715 | 21 CFR 111.375(b) | Records - manufacturing operations; written procedures |
| 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 |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16008 | 21 CFR 111.135 | Quality control operations - product complaints; investigate |