754210
Neutraderm, Inc. — FEI 3006402197
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 2, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chatsworth, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1803 | 21 CFR 211.84(b) | Representative Samples Criteria |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1922 | 21 CFR 211.166(a)(4) | Testing in same container - closure system |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4356 | 21 CFR 211.166(b) | Tentative expiration date |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |