FDA Inspection 816482 — Nature's Rite, LLC
The FDA completed an inspection of Nature's Rite, LLC on January 25, 2013 in Sarasota, FL. 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: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 25, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Sarasota, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15871 | 21 CFR 111.75(c)(2) | Specifications met - test, examinations; compliance |
| 15903 | 21 CFR 111.87 | Material review, disposition - quality control |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |