FDA Inspection 746033 — Lopez Gonzalez Santana Corporation
The FDA completed an inspection of Lopez Gonzalez Santana Corporation on September 22, 2011 in Rio Piedras, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 22, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Rio Piedras, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1632 | 21 CFR 211.130(c) | Lot or control number assigned |