FDA Inspection 1112405 — SOFGEN PHARMACEUTICALS LLC
The FDA completed an inspection of SOFGEN PHARMACEUTICALS LLC on Dec 11, 2019 in Miramar, FL. 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). 1 citation was issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 11, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Miramar, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4307 | 21 CFR 211.80(d) | Status of Each Lot Identified |