FDA Inspection 792703 — Kreativ Health, Inc. (dba Natural Foods Supplements and Sunshine Valley)
The FDA completed an inspection of Kreativ Health, Inc. (dba Natural Foods Supplements and Sunshine Valley) on July 31, 2012 in Canoga Park, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 15 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 31, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Canoga Park, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15389 | 21 CFR 111.10(b)(1) | Outer garments |
| 15410 | 21 CFR 111.14(b)(2) | Personnel - records - training |
| 15480 | 21 CFR 111.20(h) | Physical plant - screening against pests |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15675 | 21 CFR 111.315(b) | Sampling plans; establish, follow |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15975 | 21 CFR 111.120(e) | Quality control operations - quarantine |
| 15984 | 21 CFR 111.123(a)(8) | Quality control - finished batch, distribution |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |
| 16067 | 21 CFR 111.35(b)(1)(ii) | Procedures - equipment; calibrating, inspecting, checking |