1190652
Eden's Answers Inc — FEI 3012343370
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 16, 2022
- Fiscal Year
- 2023
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Holmesville, OH (United States)
Citations
| ID | CFR | Description |
|---|
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15642 | 21 CFR 111.455(a) | Hold - temperature, humidity, light |
| 15680 | 21 CFR 111.315(d) | Standard reference materials; criteria for selecting, QC |
| 15712 | 21 CFR 111.325(b)(2)(ii) | Records - document; results |
| 15733 | 21 CFR 111.365 | Manufacturing operations - prevent contamination |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15862 | 21 CFR 111.75(a)(2) | Appropriate tests, examinations; certificate of analysis |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 15902 | 21 CFR 111.83(b)(4) | Reserve sample - twice the quantity |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 15953 | 21 CFR 111.113(a)(1) | Quality control production, process control; material review, disposition |
| 15967 | 21 CFR 111.117(b) | Quality control operations - calibration records |
| 16001 | 21 CFR 111.130(a) | Quality control returned dietary supplement; material review, disposition |
| 16017 | 21 CFR 111.140(b)(3) | Records - material review, disposition documentation |
| 3080 | 21 CFR 114.83 | Scheduled process establishment |