FDA Inspection 683997 — Aloe Vera Of America, Inc
The FDA completed an inspection of Aloe Vera Of America, Inc on Sep 28, 2010 in Dallas, TX. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 20 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Sep 28, 2010
- Fiscal Year
- 2010
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Dallas, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15425 | 21 CFR 111.15(i) | Hand-washing facilities |
| 15443 | 21 CFR 111.15(b)(2) | Physical plant - repair |
| 15444 | 21 CFR 111.15(c)(1) | Cleaning compounds |
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15547 | 21 CFR 111.260(g) | Batch record - results; monitoring |
| 15619 | 21 CFR 111.180(b)(1) | Written procedures - packaging, labeling received |
| 15698 | 21 CFR 111.320(a) | Examination, testing; appropriate |
| 15709 | 21 CFR 111.325(b)(2) | Laboratory methodology followed |
| 15749 | 21 CFR 111.210(e) | Master manufacturing record - intentional overage |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15787 | 21 CFR 111.410(b) | Packaging - issuance, use |
| 15821 | 21 CFR 111.60(a) | Production, in- process control system - design, quality |
| 15831 | 21 CFR 111.70(b)(3) | Specifications - contamination limits |
| 15832 | 21 CFR 111.70(c)(1) | In-process identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15984 | 21 CFR 111.123(a)(8) | Quality control - finished batch, distribution |
| 16022 | 21 CFR 111.140(b)(3)(iv) | Material review, disposition, follow-up; identification |
| 16070 | 21 CFR 111.35(b)(2) | Document-equipment date of use, maintain, clean, sanitize |
| 1917 | 21 CFR 211.166(a)(1) | Sample size - test intervals |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |