1015304
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 5, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Merrillville, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15534 | 21 CFR 111.255(c) | Batch record - each step |
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 15546 | 21 CFR 111.260(f) | Batch record - yield |
| 15645 | 21 CFR 111.455(c) | Hold - mix-up, contamination, deterioration |
| 15737 | 21 CFR 111.210(h)(5) | Corrective action plans |
| 15740 | 21 CFR 111.210(h)(3)(ii)(A) | Instructions; components; weight, measure |
| 15741 | 21 CFR 111.210(h)(3)(i) | Components, verify weight, measure |
| 15744 | 21 CFR 111.210(h)(2) | Master manufacturing record - sampling, tests, examinations |
| 15752 | 21 CFR 111.210(c) | Master manufacturing record - components; weight, measure |
| 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 |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |
| 16072 | 21 CFR 111.35(b)(3) | Instruments, controls; calibrate date, reference std, method |