FDA Inspection 979345 — Pharmalogic Puerto Rico Inc
The FDA completed an inspection of Pharmalogic Puerto Rico Inc on Jul 22, 2016 in San Juan, PR. 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
- Jul 22, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- San Juan, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 17918 | 21 CFR 212.70(f)(1)(iv) | Correct malfunction, re-do test |