FDA Inspection 665242 — Nippon Sanso Matheson, Inc.
The FDA completed an inspection of Nippon Sanso Matheson, Inc. on June 10, 2010 in Richmond, CA. 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
- June 10, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Richmond, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1879 | 21 CFR 211.180(c) | Records not made readily available to FDA |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3567 | 21 CFR 211.84(d)(2) | Component identification test |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |