FDA Inspection 1170436 — Kobayashi America Manufacturing, LLC
The FDA completed an inspection of Kobayashi America Manufacturing, LLC on May 27, 2022 in Dalton, GA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 27, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dalton, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1079 | 21 CFR 211.22(a) | Contract drug products--lack of responsibility |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |