FDA Inspection 810289 — Thrive and Revive Ministires
The FDA completed an inspection of Thrive and Revive Ministires on November 30, 2012 in Clermont, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 22 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 30, 2012
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Clermont, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15409 | 21 CFR 111.14(b)(1) | Personnel - records - written procedures |
| 15434 | 21 CFR 111.15(d)(2) | Pest control measures |
| 15443 | 21 CFR 111.15(b)(2) | Physical plant - repair |
| 15447 | 21 CFR 111.15(c)(3) | Cleaning compounds and toxic materials - holding |
| 15453 | 21 CFR 111.16 | Written procedures - cleaning |
| 15454 | 21 CFR 111.16 | Written procedures - pest control |
| 15492 | 21 CFR 111.25(a) | Procedures - calibrating instruments |
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15652 | 21 CFR 111.465(b) | Retain reserve samples - 1 year, 2 years |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15736 | 21 CFR 111.353 | Manufacturing operations - written procedures |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15790 | 21 CFR 111.403 | Written procedures - labeling operations |
| 15791 | 21 CFR 111.403 | Written procedures -packaging operations |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15819 | 21 CFR 111.55 | Production, process controls - implement |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 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 |
| 1600 | 21 CFR 110.37(a) | General inadequacy |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |