705407
Old Fashioned Natural Products Inc — FEI 2023363
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 13, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Santa Ana, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 15404 | 21 CFR 111.12(c) | Personnel - education, training, experience |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15624 | 21 CFR 111.180(b)(3) | Documentation - components |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15832 | 21 CFR 111.70(c)(1) | In-process identity, purity, strength, composition |
| 15833 | 21 CFR 111.70(c)(1) | Specifications - in-process contamination limits |
| 15853 | 21 CFR 111.73 | Specifications met - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15935 | 21 CFR 111.105(d) | Quality control - basis; tests, examinations |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3592 | 21 CFR 211.110(c) | In-process materials characteristics testing |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |