FDA Inspection 1223082 — Laboratorios Zepol S.A.
The FDA completed an inspection of Laboratorios Zepol S.A. on November 17, 2023 in Curridabat. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 17, 2023
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Curridabat (Costa Rica)
Citations
| ID | CFR | Description |
|---|---|---|
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 1796 | 21 CFR 211.80(d) | Identification of Each Lot in Each Shipment |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1918 | 21 CFR 211.166(a)(2) | Stability sample storage conditions described |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |