683997
Aloe Vera of America, Inc — FEI 1629180
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 28, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- 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 |