FDA Inspection 685702 — Real Aloe Solutions, Inc.
The FDA completed an inspection of Real Aloe Solutions, Inc. on Oct 21, 2010 in Calipatria, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 18 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Oct 21, 2010
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Calipatria, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15482 | 21 CFR 111.23(c) | Records - water |
| 15492 | 21 CFR 111.25(a) | Procedures - calibrating instruments |
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15715 | 21 CFR 111.375(b) | Records - manufacturing operations; written procedures |
| 15760 | 21 CFR 111.205(b)(1) | Master manufacturing record-specifications; packaged, label |
| 15761 | 21 CFR 111.205(b)(1) | Master manufacturing record - specifications; quality |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15796 | 21 CFR 111.430(b) | Records - packaging, labeling operations |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15828 | 21 CFR 111.70(a) | Specifications - manufacturing process |
| 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 |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |
| 3062 | 21 CFR 114.10 | Personnel |
| 4470 | 21 CFR 108.25(c)(2) | Process filing |