FDA Inspection 1239633 — Tecnocosmesi S.P.A.
The FDA completed an inspection of Tecnocosmesi S.P.A. on May 10, 2024 in Massalengo. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 10, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Massalengo (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |