FDA Inspection 1277699 — Pace Analytical Inc.
The FDA completed an inspection of Pace Analytical Inc. on August 7, 2025 in San German, 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
- August 7, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- San German, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 4350 | 21 CFR 211.160(b)(3) | Drug products-sampling procedures/specifications |