FDA Inspection 1017026 — Gianluca Mech S.P.A.
The FDA completed an inspection of Gianluca Mech S.P.A. on Mar 18, 2017 in Asigliano Veneto. 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). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 18, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Asigliano Veneto (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15831 | 21 CFR 111.70(b)(3) | Specifications - contamination limits |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |