FDA Inspection 812882 — Aloe Vera of America, Inc
The FDA completed an inspection of Aloe Vera of America, Inc on January 11, 2013 in Dallas, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 15 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 11, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Dallas, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1126 | 21 CFR 110.40(a) | Precluding contaminants |
| 15410 | 21 CFR 111.14(b)(2) | Personnel - records - training |
| 15480 | 21 CFR 111.20(h) | Physical plant - screening against pests |
| 15546 | 21 CFR 111.260(f) | Batch record - yield |
| 15681 | 21 CFR 111.315(d) | Standard reference materials; criteria for selecting |
| 15689 | 21 CFR 111.315(b)(3) | Sampling plans; finished batches |
| 15708 | 21 CFR 111.325(a) | Written procedures, laboratory operations |
| 15741 | 21 CFR 111.210(h)(3)(i) | Components, verify weight, measure |
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |
| 15831 | 21 CFR 111.70(b)(3) | Specifications - contamination limits |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 15955 | 21 CFR 111.113(a)(3) | Quality control - adulteration; material review, disposition |
| 15968 | 21 CFR 111.117(c) | Quality control operations - equipment records |
| 15984 | 21 CFR 111.123(a)(8) | Quality control - finished batch, distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |