FDA Inspection 705407 — Old Fashioned Natural Products Inc
The FDA completed an inspection of Old Fashioned Natural Products Inc on January 13, 2011 in Santa Ana, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 19 citations were issued during this inspection. Product area: Drugs.
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. |