FDA Inspection 1231008 — Kobayashi America Manufacturing, LLC
The FDA completed an inspection of Kobayashi America Manufacturing, LLC on March 15, 2024 in Dalton, GA. 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 15, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dalton, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |