754339
Naprodis, Inc. — FEI 3004391510
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 22, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Escondido, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 15381 | 21 CFR 111.8 | Written procedures - hygienic practices |
| 15453 | 21 CFR 111.16 | Written procedures - cleaning |
| 15454 | 21 CFR 111.16 | Written procedures - pest control |
| 15544 | 21 CFR 111.260(d) | Batch record - component; unique identifier |
| 15550 | 21 CFR 111.260(j) | Batch record - manufacture |
| 15572 | 21 CFR 111.153 | Written procedures - labels |
| 15739 | 21 CFR 111.210(h)(3)(ii)(B) | Components; add, verify |
| 15740 | 21 CFR 111.210(h)(3)(ii)(A) | Instructions; components; weight, measure |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15819 | 21 CFR 111.55 | Production, process controls - implement |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15895 | 21 CFR 111.80(e) | Specifications - representative samples; packaged, labeled |
| 1798 | 21 CFR 211.82(b) | Quarantine Storage of Components |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 4376 | 21 CFR 211.188(b)(4) | Weights and measures of components used |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |