FDA Inspection 1017853 — Beau. Beau. Corp.
The FDA completed an inspection of Beau. Beau. Corp. on July 14, 2017 in Bucheon. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 14, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bucheon (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |