FDA Inspection 647663 — Living Essentials LLC
The FDA completed an inspection of Living Essentials LLC on February 19, 2010 in Farmington Hills, MI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 19, 2010
- Fiscal Year
- 2010
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Farmington Hills, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15351 | FDCA 761(b)(1) | No AE report made (dietary supplement) |
| 15358 | FDCA 761(c)(1) | Timing of AE report submission (dietary supplement) |
| 15401 | 21 CFR 111.12(b) | Personnel - quality control operations; identified |
| 15402 | 21 CFR 111.12 | Personnel - quality control personnel - qualified |
| 15410 | 21 CFR 111.14(b)(2) | Personnel - records - training |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15802 | 21 CFR 111.560(c) | Product complaint - review, investigation |
| 15806 | 21 CFR 111.570(a) | Records - product complaints: originals, copies, electroni |
| 15811 | 21 CFR 111.570(b)(2)(i) | Record - person document; time of performance |
| 15817 | 21 CFR 111.570(b)(2)(ii)(F) | Record - product complaint; findings |