FDA Inspection 971040 — Aloe Partners Inc dba The Aloe Source
The FDA completed an inspection of Aloe Partners Inc dba The Aloe Source on May 20, 2016 in Dallas, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 20, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Dallas, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1066 | 21 CFR 110.40(b) | Seams on food contact surfaces |
| 1293 | 21 CFR 110.20(b)(2) | Contamination with microorganisms, chemicals, filth, etc. |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 1798 | 21 CFR 211.82(b) | Quarantine Storage of Components |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2044 | 21 CFR 211.196 | Distribution Record Requirements |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 4328 | 21 CFR 211.122(a) | Written procedures not followed |
| 4338 | 21 CFR 211.150(b) | Recall facilitation |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |