FDA Inspection 1045976 — Nutreglo Products, LLC.
The FDA completed an inspection of Nutreglo Products, LLC. on March 26, 2018 in Fort Lauderdale, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 26, 2018
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Fort Lauderdale, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15409 | 21 CFR 111.14(b)(1) | Personnel - records - written procedures |
| 15431 | 21 CFR 111.15(e)(1) | Water supply - not component - suitability |
| 15481 | 21 CFR 111.23(b) | Records - cleaning, pest control |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15620 | 21 CFR 111.180(b)(1) | Written procedures - product received |
| 15624 | 21 CFR 111.180(b)(3) | Documentation - components |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 16013 | 21 CFR 111.140(b)(1) | Records - quality control operations; responsibilities |
| 16043 | 21 CFR 111.503 | Written procedures - returned dietary supplement; destroyed |
| 16069 | 21 CFR 111.35(b)(1)(iii) | Procedures contact surfaces; maintaining, cleaning, sanitize |