FDA Inspection 953968 — Nippon Sanso Matheson, Inc.
The FDA completed an inspection of Nippon Sanso Matheson, Inc. on Dec 10, 2015 in Tyler, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 10, 2015
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tyler, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 2020 | 21 CFR 211.188(b)(8) | Labeling Control Records and Label Copies |
| 4302 | 21 CFR 211.56(b) | Written sanitation procedures not followed |