FDA Inspection 955455 — Lusochimica S.P.A.
The FDA completed an inspection of Lusochimica S.P.A. on Oct 30, 2015 in Lomagna. 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 30, 2015
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lomagna (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 17743 | 21 CFR 212.30(b) | Equipment procedures overall |
| 17853 | 21 CFR 212.60(d) | Supplies adequately controlled |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |