FDA Inspection 820288 — Dimensional Merchandising Inc. DBA DMI Solutions
The FDA completed an inspection of Dimensional Merchandising Inc. DBA DMI Solutions on March 15, 2013 in Wharton, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 15, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Wharton, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |