FDA Inspection 1008335 — Nippon Sanso Matheson, Inc.
The FDA completed an inspection of Nippon Sanso Matheson, Inc. on April 5, 2017 in Bangor, ME. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 5, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bangor, ME (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 3569 | 21 CFR 211.89 | Quarantine of Rejected Components et. al. |