FDA Inspection 1051225 — PRC Ticinum Lab, S.R.L.
The FDA completed an inspection of PRC Ticinum Lab, S.R.L. on May 9, 2018 in Novara. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 9, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Novara (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 2399 | 21 CFR 211.194(a)(2) | Laboratory Test Method Verification |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 4344 | 21 CFR 211.160(b)(1) | Sampling and testing procedures described |