FDA Inspection 879985 — Unimed Pharmaceuticals, Inc.
The FDA completed an inspection of Unimed Pharmaceuticals, Inc. on May 1, 2014 in Asan. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 1, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Asan (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2198 | 21 CFR 211.186(b)(3) | Component Name and Code |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |