FDA Inspection 1045597 — MicroBiopharm Japan Co., Ltd.
The FDA completed an inspection of MicroBiopharm Japan Co., Ltd. on March 16, 2018 in Iwata. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 16, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Iwata (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |